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Trial record 80 of 107 for:    ( Map: Nepal )

Premedication With Melatonin and Alprazolam Combination Versus Alprazolam or Melatonin Alone

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ClinicalTrials.gov Identifier: NCT01486615
Recruitment Status : Completed
First Posted : December 6, 2011
Results First Posted : October 5, 2012
Last Update Posted : October 5, 2012
Sponsor:
Information provided by (Responsible Party):
Krishna Pokharel, B.P. Koirala Institute of Health Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Anxiety
Interventions Drug: meloset (melatonin)
Drug: stresnil ( melatonin and alprazolam)
Drug: (alprax) alprazolam
Drug: placebo
Enrollment 80

Recruitment Details Recruitment period was of three months. Approximately 90 minutes prior to surgery, each patient was taken to a quiet room inside the operation theater complex.
Pre-assignment Details One hundred and ten patients were assessed for eligibility, 98 patients had anxiety VAS ≥3. Among them, 80 patients who met the inclusion criteria, were enrolled and assigned into four groups.
Arm/Group Title Melatonin Melatonin and Alprazolam Alprazolam Placebo
Hide Arm/Group Description Oral premedication with 3 mg melatonin tablet (Meloset) 1-2 hour prior to anesthesia Oral premedication with a 3 mg melatonin and 0.5 mg alprazolam combination tablet (Stressnil) 1-2 hrs prior to anesthesia Oral premedication with 0.5 mg alprazolam (Alprax) 1-2 hr prior to anesthesia Oral premedication with a similar looking placebo tablet 1-2 hr prior to anesthesia
Period Title: Overall Study
Started 20 20 20 20
Completed 20 19 [1] 18 [1] 18 [1]
Not Completed 0 1 2 2
[1]
observed till 2 hrs after premedication, not available after 24 hours as surgery was postponed
Arm/Group Title Melatonin Melatonin and Alprazolam Alprazolam Placebo Total
Hide Arm/Group Description premedication 1-2 hour prior to anesthesia premedicated 1-2 hrs prior to anesthesia premedication 1-2 hr prior to anesthesia premedication 1-2 hr prior to anesthesia Total of all reporting groups
Overall Number of Baseline Participants 20 20 20 20 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
20
 100.0%
20
 100.0%
20
 100.0%
80
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 participants
33.8  (10.9) 38.0  (13.5) 36.9  (10.0) 36.2  (12.9) 36  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 participants
Female
16
  80.0%
14
  70.0%
16
  80.0%
15
  75.0%
61
  76.3%
Male
4
  20.0%
6
  30.0%
4
  20.0%
5
  25.0%
19
  23.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Nepal Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 participants
20 20 20 20 80
Vas baseline (cm)   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Centimeters
Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 participants
5
(4 to 6)
5
(3.6 to 6)
5
(4.2 to 7)
5
(4 to 6)
5
(4 to 6)
[1]
Measure Description: VAS (Visual Analogue Score) Anxiety Scale is 10 cm long and has the patient's side (front) and the clinician's side (back). The extremes of the front are colored as white and black; with a gradual darkening of color from white to black in between. The back is marked in centimeter from 0 to 10 and 0 correlates with white color (no anxiety at all) and 10 correlates to black color (anxiety as bad as ever can be). The patient is asked to point at the color on the scale according to his anxiety level. As anxiety is worsened, the score is more. The maximum value of assessment is 10 and minimum is 0.
Anaesthesia time  
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 participants
65.8  (18.1) 77.2  (34.3) 73.7  (21.0) 71.7  (17.6) 71.6  (23.7)
1.Primary Outcome
Title Change in VAS Anxiety Score Relative to Baseline After Premedication
Hide Description VAS (Visual Analogue Score) Anxiety Scale is a 10 cm long scale with two sides, the patient side (front) and the clinicians side (back). The extremes of the front are colored as white and black with a gradual darkening of color from white to black. The back is marked in centimeter from 0 to 10 and 0 correlates with white color (no anxiety at all) and 10 correlates to black color (anxiety as bad as ever can be) on the front. As anxiety is worsened, the color is darker and score is more. The maximum score is 10 and minimum 0. The patient is asked to point on the scale according to his anxiety level. The anxiety score is the correlating number on the clinicians side. The more the reduction in anxiety from baseline, the better the outcome.
Time Frame Change from baseline in VAS anxiety score at 15 minutes after premedication
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
sample size of 16 patients in each group was determined by a power analysis (α, 0.05; β, 0.10) assuming that there will be 50% reduction in anxiety VAS from baseline in the experimental groups and 4% in the placebo group. To compensate for dropout cases and shifting from normality in data distribution, 20 cases were studied in each group.
Arm/Group Title Melatonin Melatonin and Alprazolam Alprazolam Placebo
Hide Arm/Group Description:
premedicated 1-2 hour before anesthesia
premedicated 1-2 hrs before anesthesia
premedicated 1-2 hours before anesthesia
premedicated 1-2 hours before anesthesia
Overall Number of Participants Analyzed 20 20 20 20
Mean (Standard Deviation)
Unit of Measure: Centimeter
0.35  (0.8) 0.70  (1.6) 0.65  (1.2) 0.25  (0.8)
2.Primary Outcome
Title Change in VAS Anxiety Score Relative to Baseline at 30 Minutes After Premedication
Hide Description VAS (Visual Analogue Score) Anxiety Scale is a 10 cm long scale with two sides, the patient side (front) and the clinicians side (back). The extremes of the front are colored as white and black with a gradual darkening of color from white to black. The back is marked in centimeter from 0 to 10 and 0 correlates with white color (no anxiety at all) and 10 correlates to black color (anxiety as bad as ever can be) on the front. As anxiety is worsened, the color is darker and score is more. The maximum score is 10 and minimum 0. The patient is asked to point on the scale according to his anxiety level. The anxiety score is the correlating number on the clinicians side. The more the reduction in anxiety from baseline, the better the outcome.
Time Frame Changes from baseline in VAS anxiety score at 30 minutes after premedication
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Melatonin Melatonin and Alprazolam Alprazolam Placebo
Hide Arm/Group Description:
premedicated 1-2 hour before anesthesia
premedicated 1-2 hrs before anesthesia
premedicated 1-2 hours before anesthesia
premedicated 1-2 hours before anesthesia
Overall Number of Participants Analyzed 20 20 20 20
Mean (Standard Deviation)
Unit of Measure: centimeter
1.15  (1.4) 1.72  (2.2) 1.62  (1.6) 0.82  (1.6)
3.Primary Outcome
Title Change in VAS Anxiety Score Relative to Baseline at One Hour After Premedication
Hide Description VAS (Visual Analogue Score) Anxiety Scale is a 10 cm long scale with two sides, the patient side (front) and the clinicians side (back). The extremes of the front are colored as white and black with a gradual darkening of color from white to black. The back is marked in centimeter from 0 to 10 and 0 correlates with white color (no anxiety at all) and 10 correlates to black color (anxiety as bad as ever can be) on the front. As anxiety is worsened, the color is darker and score is more. The maximum score is 10 and minimum 0. The patient is asked to point on the scale according to his anxiety level. The anxiety score is the correlating number on the clinicians side. The more the reduction in anxiety from baseline, the better the outcome.
Time Frame Changes from baseline in VAS anxiety score at one hour after premedication
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Melatonin Melatonin and Alprazolam Alprazolam Placebo
Hide Arm/Group Description:
premedicated 1-2 hour before anesthesia
premedicated 1-2 hrs before anesthesia
premedicated 1-2 hours before anesthesia
premedicated 1-2 hours before anesthesia
Overall Number of Participants Analyzed 20 20 20 20
Mean (Standard Deviation)
Unit of Measure: Centimeter
1.80  (1.7) 2.92  (2.3) 2.35  (2.1) 0.85  (1.9)
4.Secondary Outcome
Title Sedation Score at One Hour After Premedication
Hide Description Sedation level was assessed with a 5 point scale (0=alert, 1=arouses to voice, 2=arouses with gentle tactile stimulation, 3=arouses with vigorous tactile stimulation, 4=lack of responsiveness). Minimum score is 0 and Maximum is 4. The lesser the score, the better the outcome.
Time Frame Sedation score at 1 hour after the premedication
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Melatonin Melatonin and Alprazolam Alprazolam Placebo
Hide Arm/Group Description:
premedicated 1-2 hour before anesthesia
premedicated 1-2 hrs before anesthesia
premedicated 1-2 hours before anesthesia
premedicated 1-2 hours before anesthesia
Overall Number of Participants Analyzed 20 20 20 20
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
0.5
(0 to 1)
1
(1 to 2.75)
1
(0 to 1.75)
0
(0 to 1)
5.Secondary Outcome
Title Orientation Score
Hide Description Orientation was assessed with a 3 point scale (0=none, 1=orientation in either time or place, 2=orientation in both). Minimum score is 0 and maximum is 2. The lesser the score, the lesser the effect on patients cognition and the better the outcome.
Time Frame Orientation score at one hour after premedication
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Melatonin Melatonin and Alprazolam Alprazolam Placebo
Hide Arm/Group Description:
premedicated 1-2 hour before anesthesia
premedicated 1-2 hrs before anesthesia
premedicated 1-2 hours before anesthesia
premedicated 1-2 hours before anesthesia
Overall Number of Participants Analyzed 20 20 20 20
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
2
(2 to 2)
2
(2 to 2)
2
(2 to 2)
2
(2 to 2)
6.Secondary Outcome
Title Number of Patients With Intact Memory
Hide Description Number of patients who recalled or recognized the picture number five shown one hour after premedication. The more the number of patients with intact memory, the better the outcome.
Time Frame 24 hour after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Melatonin Melatonin and Alprazolam Alprazolam Placebo
Hide Arm/Group Description:
premedicated 1-2 hour before anesthesia
premedicated 1-2 hrs before anesthesia
premedicated 1-2 hours before anesthesia
premedicated 1-2 hours before anesthesia
Overall Number of Participants Analyzed 20 19 18 18
Measure Type: Number
Unit of Measure: Participants
13 4 5 14
7.Secondary Outcome
Title Amount of Propofol Consumption
Hide Description Dose of propofol needed for loss of response to verbal command was noted at the time of induction of general anesthesia. The lesser the propofol needed for the loss of response to verbal command, the better the outcome.
Time Frame 1 - 2 hour after premedication
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Melatonin Melatonin and Alprazolam Alprazolam Placebo
Hide Arm/Group Description:
premedicated 1-2 hour before anesthesia
premedicated 1-2 hrs before anesthesia
premedicated 1-2 hours before anesthesia
premedicated 1-2 hours before anesthesia
Overall Number of Participants Analyzed 20 19 18 18
Mean (Standard Deviation)
Unit of Measure: mg
79.2  (4) 65.5  (21) 59.0  (21) 75.8  (25)
8.Secondary Outcome
Title Number of Patients With Loss of Memory for Being Transferred to Operating Room.
Hide Description Patients were asked whether they recalled the event of being transferred to the operating room before anaesthesia. The lesser the number of patients with amnesia, the better the outcome.
Time Frame 24 hour after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Melatonin Melatonin and Alprazolam Alprazolam Placebo
Hide Arm/Group Description:
premedicated 1-2 hour before anesthesia
premedicated 1-2 hrs before anesthesia
premedicated 1-2 hours before anesthesia
premedicated 1-2 hours before anesthesia
Overall Number of Participants Analyzed 20 19 18 18
Measure Type: Number
Unit of Measure: Participants
1 5 4 0
Time Frame 24 hours after premedication
Adverse Event Reporting Description

Incidence of nausea and vomiting were recorded.

Vitals (Blood Pressure, Heart Rate, Respiratory rate and Temperature) were assessed every 6 hours.

 
Arm/Group Title Melatonin Melatonin and Alprazolam Alprazolam Placebo
Hide Arm/Group Description premedication 1-2 hour prior to anesthesia premedicated 1-2 hrs prior to anesthesia premedication 1-2 hr prior to anesthesia premedication 1-2 hr prior to anesthesia
All-Cause Mortality
Melatonin Melatonin and Alprazolam Alprazolam Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Melatonin Melatonin and Alprazolam Alprazolam Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/19 (0.00%)      0/18 (0.00%)      0/18 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Melatonin Melatonin and Alprazolam Alprazolam Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/20 (65.00%)      12/19 (63.16%)      14/18 (77.78%)      16/18 (88.89%)    
Gastrointestinal disorders         
Nausea and Vomiting   6/20 (30.00%)  8 7/19 (36.84%)  10 8/18 (44.44%)  11 9/18 (50.00%)  12
General disorders         
Restlessness *  6/20 (30.00%)  6 7/19 (36.84%)  7 9/18 (50.00%)  9 8/18 (44.44%)  8
Nervous system disorders         
Dizziness *  5/20 (25.00%)  7 3/19 (15.79%)  5 2/18 (11.11%)  4 4/18 (22.22%)  5
Headache   4/20 (20.00%)  4 4/19 (21.05%)  4 3/18 (16.67%)  3 5/18 (27.78%)  5
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
The study was not designed to measure drug plasma concentrations. We did not perform a battery of tests to evaluate psychomotor and amnesic performances. We only did an orientation score and assessed delayed visual episodic memory.
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
Name/Title: Dr Krishna Pokharel
Organization: B. P. Koirala Institute of Health Sciences
Phone: 0977-9841986321
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Krishna Pokharel, B.P. Koirala Institute of Health Sciences
ClinicalTrials.gov Identifier: NCT01486615     History of Changes
Other Study ID Numbers: 2/18 (Acd. 796/067/068)
First Submitted: November 10, 2011
First Posted: December 6, 2011
Results First Submitted: May 20, 2012
Results First Posted: October 5, 2012
Last Update Posted: October 5, 2012