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Preoperative Gabapentin Versus Bisoprolol for Hemodynamic Optimization During Sinus Surgery

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ClinicalTrials.gov Identifier: NCT03850093
Recruitment Status : Completed
First Posted : February 21, 2019
Results First Posted : August 12, 2019
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
abeer M. elnakera, Zagazig University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Blood Pressure
Interventions Drug: Gabapentin1200 mg
Drug: bisoprolol 2.5mg
Drug: placebo
Enrollment 63
Recruitment Details 66 patients who underwent endoscopic sinus surgery were eligible for the study
Pre-assignment Details  
Arm/Group Title Gabapentin Group (Group G) Bisoprolol Group (Group B) Control Group (Group C)
Hide Arm/Group Description 21 patients completed the study and were considered for statistical analysis 22 patients were allocated to group B, completed the study and were considered for statistical analysis 17 patients completed the study and were considered for statistical analysis
Period Title: Overall Study
Started 22 22 19
Completed 21 22 17
Not Completed 1 0 2
Reason Not Completed
Withdrawal by Subject             1             0             2
Arm/Group Title Gabapentin Bisoprolol Control Total
Hide Arm/Group Description gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative placebo was given to patients of control group 2 hours preoperative Total of all reporting groups
Overall Number of Baseline Participants 21 22 17 60
Hide Baseline Analysis Population Description
63 patients were enrolled in the study. after 3 patients' withdrawal, 60 patients completed the study and considered for statistical analysis
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 22 participants 17 participants 60 participants
27.1  (7.6) 30.5  (6.6) 28.6  (5.1) 27.93  (6.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 22 participants 17 participants 60 participants
Female
8
  38.1%
9
  40.9%
6
  35.3%
23
  38.3%
Male
13
  61.9%
13
  59.1%
11
  64.7%
37
  61.7%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
weight, continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 21 participants 22 participants 17 participants 60 participants
87.1  (1.1) 87.9  (11.9) 84.5  (11.5) 85.62  (11.5)
[1]
Measure Analysis Population Description: patients' withdrawal from the study
indication for surgery, categorical)   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 22 participants 17 participants 60 participants
polyp
11
  52.4%
13
  59.1%
10
  58.8%
34
  56.7%
sinusitis
10
  47.6%
9
  40.9%
7
  41.2%
26
  43.3%
[1]
Measure Description: indication for surgery is either due to polyp or sinusitis
[2]
Measure Analysis Population Description: 3 patients were withdrawn from the study
mean arterial blood pressure (MAP), continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 21 participants 22 participants 17 participants 60 participants
96.6  (7.5) 92.9  (7.4) 88.2  (11.7) 93.4  (9.7)
[1]
Measure Analysis Population Description: 3 patients were withdrawn from the study
heart rate (HR), continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Beats/minute
Number Analyzed 21 participants 22 participants 17 participants 60 participants
91.1  (11.6) 82.9  (6.4) 83.8  (14.8) 86.7  (11.98)
[1]
Measure Analysis Population Description: 3 patients were withdrawn from the study
side of surgery   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 22 participants 17 participants 60 participants
bilateral
14
  66.7%
11
  50.0%
9
  52.9%
34
  56.7%
unilateral
7
  33.3%
11
  50.0%
8
  47.1%
26
  43.3%
[1]
Measure Description: side of surgery is either bilateral or unilateral
[2]
Measure Analysis Population Description: 3 patients were withdrawn from the study
1.Primary Outcome
Title Mean Arterial Blood Pressure Change
Hide Description effect of intervention on the change of mean arterial blood pressure allover study period
Time Frame were recorded before oral premedication (baseline), pre-induction, after induction of anesthesia, 1, 5, 10, 15 minutes after intubation and then every 15 minutes until the end of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gabapentin Bisoprolol Control
Hide Arm/Group Description:
gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative
bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
placebo was given to patients of control group 2 hours preoperative
Overall Number of Participants Analyzed 21 22 17
Mean (Standard Deviation)
Unit of Measure: mm Hg
preinduction 85.6  (6) 86.4  (6.6) 92.4  (9.8)
after induction 74.4  (6.9) 72.3  (9.9) 78.2  (9.1)
1 minute after intubation 80.6  (7.6) 76.2  (12.9) 92.2  (16.1)
5 minutes after intubation 70.7  (8.4) 67.2  (7.8) 78.6  (11.1)
10 minutes after intubation 66.4  (7.1) 67.7  (10.4) 76.5  (12.9)
15 minutes after intubation 65.4  (4.6) 70.2  (8.8) 74  (12.1)
30 minutes after intubation 64.4  (4.4) 66.2  (6.8) 66.6  (21.7)
45 minutes after intubation 63.3  (3.4) 64.7  (6.6) 64.6  (14.3)
60 minutes after intubation 61.9  (4.2) 66.7  (4.8) 69.9  (11.3)
75 minutes after intubation 62.5  (4.4) 69.4  (8.4) 67.7  (5.5)
90 minutes after intubation 63  (3.5) 66.1  (4.7) 62.7  (12.8)
105 minutes after intubation 63.1  (3) 67.2  (7.7) 70  (14.8)
2.Primary Outcome
Title Changes in Surgical Field Visibility
Hide Description

according to change in Fromm and Boezaart surgical field category scale ranging from 0 (no bleeding) to 5 (severe bleeding) where: 0 No Bleeding.

  1. Slight bleeding- no blood suctioning required.
  2. Slight bleeding- occasional blood suctioning required.
  3. Slight bleeding- frequent blood suctioning required, operative field is visible for some seconds after evacuation.
  4. Moderate bleeding- frequent blood suctioning required, operative field is only visible immediately after evacuation.
  5. Severe bleeding- constant blood suctioning required, bleeding appears faster than can be removed by suction .Surgery is hardly possible, and sometimes impossible.
Time Frame scale was assessed by the surgeon every 15 minutes from the start of surgical procedure till the end
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gabapentin Bisoprolol Control
Hide Arm/Group Description:
gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative
bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
placebo was given to patients of control group 2 hours preoperative
Overall Number of Participants Analyzed 21 22 17
Median (Full Range)
Unit of Measure: score on a scale
15 minutes
2
(2 to 3)
2
(1 to 3)
4
(3 to 4)
30 minutes
1
(1 to 3)
1
(1 to 2)
3
(2 to 4)
45 minutes
1
(0 to 2)
1
(1 to 3)
3
(2 to 3)
60 minutes
1
(0 to 1)
1
(1 to 2)
3
(3 to 4)
75 minutes
1
(1 to 2)
1
(0 to 2)
2
(2 to 3)
90 minutes
1
(0 to 2)
0
(0 to 2)
3
(2 to 3)
105 minutes
1
(0 to 2)
0
(0 to 2)
2
(2 to 3)
3.Primary Outcome
Title Heart Rate Change
Hide Description effect of intervention on the change of heart rate allover study period
Time Frame were recorded before oral premedication (baseline), pre-induction, after induction of anesthesia, 1, 5, 10, 15 minutes after intubation and then every 15 minutes until the end of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gabapentin Bisoprolol Control
Hide Arm/Group Description:
gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative
bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
placebo was given to patients of control group 2 hours preoperative
Overall Number of Participants Analyzed 21 22 17
Mean (Standard Deviation)
Unit of Measure: beats/ minute
preinduction 82.6  (10.4) 73.1  (9.5) 85.8  (16)
after induction 74.9  (11.8) 67.8  (6.8) 85.9  (16.7)
1 minute after intubation 83.3  (11.1) 73.3  (9.4) 96.2  (18.8)
5 minutes after intubation 77.1  (10) 70.6  (8.8) 89.3  (17.5)
10 minutes after intubation 75.4  (8.6) 66.3  (5.4) 87.8  (19.1)
15 minutes after intubation 74.7  (8.8) 66.6  (5.8) 90.2  (19.8)
30 minutes after intubation 73.4  (9.4) 67.7  (4.9) 85.8  (14.3)
45 minutes after intubation 75  (7.4) 67.1  (4.2) 80.1  (14.7)
60 minutes after intubation 75.3  (7.4) 66.3  (4.8) 87.3  (13.5)
75 minutes after intubation 75.7  (8.9) 66  (4.3) 84.5  (14.1)
90 minutes after intubation 72.7  (8.4) 66.5  (3.4) 88.1  (14.3)
105 minutes after intubation 75.7  (8.1) 67.4  (5.7) 97  (13.2)
4.Primary Outcome
Title Number of Patients Who Recieved Intraoperative IV Nitroglycerin During Operative Procedure
Hide Description need for additional intraoperative IV vasodilators (nitroglycerine
Time Frame at the end of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gabapentin Bisoprolol Control
Hide Arm/Group Description:
gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative
bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
placebo was given to patients of control group 2 hours preoperative
Overall Number of Participants Analyzed 21 22 17
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
5
  29.4%
5.Primary Outcome
Title Number of Patients Who Recieved Intraoperative IV Propranolol During Operative Procedure
Hide Description the need for additional beta blockers (propranolol)
Time Frame at the end of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gabapentin Bisoprolol Control
Hide Arm/Group Description:
gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative
bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
placebo was given to patients of control group 2 hours preoperative
Overall Number of Participants Analyzed 21 22 17
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
   5.9%
6.Primary Outcome
Title Number of Patients Who Recieve Both IV Nitroglycerin and Propranolol During Operative Procedure
Hide Description need for both IV nitroglycerine and propranolol intraoperatively
Time Frame at the end of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gabapentin Bisoprolol Control
Hide Arm/Group Description:
gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative
bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
placebo was given to patients of control group 2 hours preoperative
Overall Number of Participants Analyzed 21 22 17
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
6
  35.3%
7.Secondary Outcome
Title Blood Loss
Hide Description total intraoperative blood loss (mL)
Time Frame at the end of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gabapentin Bisoprolol Control
Hide Arm/Group Description:
gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative
bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
placebo was given to patients of control group 2 hours preoperative
Overall Number of Participants Analyzed 21 22 17
Median (Full Range)
Unit of Measure: mL
20
(10 to 40)
20
(10 to 30)
80
(30 to 110)
8.Secondary Outcome
Title Change in Postoperative Visual Analogue Score (VAS) for Pain
Hide Description VAS for pain score where 0 is no pain and 10 severe intolerable pain
Time Frame 1, 3 and 6 hours after recovery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gabapentin Bisoprolol Control
Hide Arm/Group Description:
gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative
bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
placebo was given to patients of control group 2 hours preoperative
Overall Number of Participants Analyzed 21 22 17
Median (Full Range)
Unit of Measure: score on a scale
1 hour after recovery
2
(0 to 4)
4
(3 to 5)
5
(4 to 6)
3 hours after recovery
1
(0 to 3)
3
(2 to 4)
4
(3 to 4)
6 hours after recovery
1
(0 to 3)
3
(2 to 4)
3
(2 to 4)
9.Secondary Outcome
Title Surgeon Satisfaction (Categorical)
Hide Description surgeon satisfaction score where given 5 for very satisfied, 4 for satisfied, 3 for neutral, 2 for dissatisfied and 1 for very dissatisfied then number of satisfied (satisfaction score = 5) and disatisfied (satisfaction score less than 5) surgeons was compared between groups
Time Frame at the end of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gabapentin Bisoprolol Control
Hide Arm/Group Description:
gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative
bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
placebo was given to patients of control group 2 hours preoperative
Overall Number of Participants Analyzed 21 22 17
Measure Type: Count of Participants
Unit of Measure: Participants
surgeon satisfaction achieved (score≥ 4)
21
 100.0%
22
 100.0%
10
  58.8%
surgeon satisfaction not achieved(score< 4)
0
   0.0%
0
   0.0%
7
  41.2%
Time Frame intra-operative and up to 6 hours postoperative
Adverse Event Reporting Description hypertension:MAP elevation by more than 20% from baseline value hypotension : systolic arterial pressure (SAP) less than 90 mmHg tachycardia : HR more than 90 beats/min bradycardia: HR less than 60 beats/min incidence of nausea and vomiting
 
Arm/Group Title Gabapentin Bisoprolol Control
Hide Arm/Group Description gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative placebo was given to patients of control group 2 hours preoperative
All-Cause Mortality
Gabapentin Bisoprolol Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)      0/22 (0.00%)      0/17 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Gabapentin Bisoprolol Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/21 (0.00%)      5/22 (22.73%)      11/17 (64.71%)    
Cardiac disorders       
hypotension * [1]  0/21 (0.00%)  1/22 (4.55%)  7/17 (41.18%) 
bradycardia * [2]  0/21 (0.00%)  4/22 (18.18%)  4/17 (23.53%) 
*
Indicates events were collected by non-systematic assessment
[1]
SAP less than 90 mmHg
[2]
HR less than 60 beats/min
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Gabapentin Bisoprolol Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/21 (0.00%)      3/22 (13.64%)      10/17 (58.82%)    
Cardiac disorders       
hypertension * [1]  0/21 (0.00%)  0 0/22 (0.00%)  0 10/17 (58.82%)  20
tachycardia * [2]  0/21 (0.00%)  0 0/22 (0.00%)  0 9/17 (52.94%)  18
Gastrointestinal disorders       
postoperative nausea *  0/21 (0.00%)  0 3/22 (13.64%)  6 5/17 (29.41%)  10
postoperative vomiting *  0/21 (0.00%)  0 0/22 (0.00%)  0 1/17 (5.88%)  1
Nervous system disorders       
agitation on recovery * [3]  0/21 (0.00%)  0 0/22 (0.00%)  0 5/17 (29.41%)  5
*
Indicates events were collected by non-systematic assessment
[1]
MAP elevation by more than 20% from baseline
[2]
HR more than 90 beats/min
[3]
Richmond Agitation Sedation Scale (RASS) equal +2
small sample size, short study period (until 6 hrs. postoperatively) and unavailability of BIS index monitoring.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: assistant professor Abeer M. Elnakera
Organization: faculty of medicine- Zagazig university
Phone: 00201005720754
EMail: nakera35@hotmail.com
Layout table for additonal information
Responsible Party: abeer M. elnakera, Zagazig University
ClinicalTrials.gov Identifier: NCT03850093     History of Changes
Other Study ID Numbers: ZU-IRB 2139-24-5-2015
First Submitted: February 18, 2019
First Posted: February 21, 2019
Results First Submitted: February 22, 2019
Results First Posted: August 12, 2019
Last Update Posted: August 12, 2019