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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

Brief Summary:

the current study hypothesized that Gabapentin can be effective as Bisoprolol in reduction of intraoperative bleeding, improving the operative's field visibility and increase the surgeon satisfaction via augmenting the reduction of blood pressure and heart rate.

A prospective randomized double blinded controlled study. Eligible patients were randomized according to random list generated software and allocated into 3 equal and matched groups (15 patients in each group):-

  • Group G: gabapentin group in which Patients were premedicated with oral gabapentin 1200 mg (Conventin 400mg; Evapharm) with sips of water, 2 hours before induction of anesthesia.
  • Group B: bisoprolol group in which Patients were premedicated with oral bisoprolol 2.5 mg ( Concor 2.5mg ; Merck/Amoun ) with sips of water, 2 hours before induction of anesthesia.
  • Group C: control group in which Patients were premedicated with oral placebo with sips of water, 2 hours before induction of anesthesia.

Condition or disease Intervention/treatment Phase
Blood Pressure Drug: Gabapentin1200 mg Drug: bisoprolol 2.5mg Drug: placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preoperative Gabapentin Versus Bisoprolol for Intraoperative Hemodynamic and Surgical Field Optimization During Endoscopic Sinus Surgery
Actual Study Start Date : August 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: gabapentin
gabapentin 1200 mg was given to patients of gabapentin group 2 hours preoperative
Drug: Gabapentin1200 mg
patients received 1200mg gabapentin 2 hrs preoperative
Other Name: gaptin

Active Comparator: bisoprolol
bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
Drug: bisoprolol 2.5mg
patients received 2.5mg bisoprolol 2 hrs preoperative
Other Name: concor

Placebo Comparator: control
placebo was given to patients of control group 2 hours preoperative
Drug: placebo
patients received oral placebo 2 hrs preoperative
Other Name: vitamins




Primary Outcome Measures :
  1. Mean Arterial Blood Pressure Change [ 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 ]
    effect of intervention on the change of mean arterial blood pressure allover study period

  2. Changes in Surgical Field Visibility [ Time Frame: scale was assessed by the surgeon every 15 minutes from the start of surgical procedure till the end ]

    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.

  3. Heart Rate Change [ 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 ]
    effect of intervention on the change of heart rate allover study period

  4. Number of Patients Who Recieved Intraoperative IV Nitroglycerin During Operative Procedure [ Time Frame: at the end of surgery ]
    need for additional intraoperative IV vasodilators (nitroglycerine

  5. Number of Patients Who Recieved Intraoperative IV Propranolol During Operative Procedure [ Time Frame: at the end of surgery ]
    the need for additional beta blockers (propranolol)

  6. Number of Patients Who Recieve Both IV Nitroglycerin and Propranolol During Operative Procedure [ Time Frame: at the end of surgery ]
    need for both IV nitroglycerine and propranolol intraoperatively


Secondary Outcome Measures :
  1. Blood Loss [ Time Frame: at the end of surgery ]
    total intraoperative blood loss (mL)

  2. Change in Postoperative Visual Analogue Score (VAS) for Pain [ Time Frame: 1, 3 and 6 hours after recovery ]
    VAS for pain score where 0 is no pain and 10 severe intolerable pain

  3. Surgeon Satisfaction (Categorical) [ Time Frame: at the end of surgery ]
    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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients who underwent functional endoscopic sinus surgery
  • ability to swallow tablets

Exclusion Criteria:

  • suspected difficult airway
  • basal HR <60/min.
  • chronic cardiovascular or cerebrovascular disease
  • bronchial asthma or COPD
  • DM
  • bleeding disorders
  • anemia (Hb level< 10 gm/dl)
  • renal or hepatic insufficiency
  • psychiatric disorders
  • chronic treatment by BBs, gabapentin or drugs that affect coagulation
  • acute nasal infection
  • allergy/contraindications to any of the study's drugs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03850093


Sponsors and Collaborators
Zagazig University
Investigators
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Principal Investigator: Abeer M. Elnakera, doctorate faculty of medicine - Zagazig university
Study Chair: Ayman A. Hassan, doctorate Zagazig University
Study Chair: Maram wagdy, Master Zagazig University
Study Chair: Mohamed W. El-Anwar, doctorate Zagazig University
  Study Documents (Full-Text)

Documents provided by abeer M. elnakera, Zagazig University:
Statistical Analysis Plan  [PDF] December 15, 2016


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Responsible Party: abeer M. elnakera, assistant professor of anesthesia and surgical intensive care, Zagazig University
ClinicalTrials.gov Identifier: NCT03850093     History of Changes
Other Study ID Numbers: ZU-IRB 2139-24-5-2015
First Posted: February 21, 2019    Key Record Dates
Results First Posted: August 12, 2019
Last Update Posted: August 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: collective data sheet was available to all researchers during and after completing the study. individual patient records are available on request for all researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by abeer M. elnakera, Zagazig University:
gabapentin
bisoprolol
hemodynamic
surgical field
Additional relevant MeSH terms:
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Bisoprolol
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents