Comparison of the effect of melatonin and zolpidem at the beginning and hours of sleep after laparoscopic abdominal surgery.
Design
Clinical trial, with parallel groups, double-blind, simple randomized, phase 4, on 168 patients who underwent laparoscopic abdominal surgery in affiliated hospitals of Islamic Azad University of Tehran.
Settings and conduct
The subjects to be studied will be selected from among the patients who undergo laparoscopic abdominal surgery in the affiliated hospitals of Tehran Islamic Azad University in 1402 and who meet the inclusion criteria so that the sample size reaches the desired number. Then the patients are divided into three simple random double-blind groups, which are matched in terms of age and gender.
Participants/Inclusion and exclusion criteria
156 patients undergoing laparoscopic abdominal surgery with general anesthesia class ASA 1, 2 referred to Islamic Azad University hospitals in 2011
Inclusion criteria
1. Age between 20 and 50 years
2. Anesthesia class ASA1,2
4. Consent to participate in the study
5. Male gender
6. Laparoscopic abdominal surgery
7. The duration of surgery is less than one hour
Exclusion criteria
1. Emergency surgery
2. Pregnant women or possibility of pregnancy
3. Diabetic, cardiac, pulmonary and neurological patients
4. Having a history of sleep disorders
Intervention groups
Intervention group 1: In this group, patients who have undergone laparoscopic abdominal surgery will receive melatonin.
Intervention group two: In this group, patients who underwent laparoscopic abdominal surgery will receive zolpidem.
Main outcome variables
Start and number of hours of sleep
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221015056176N1
Registration date:2023-08-12, 1402/05/21
Registration timing:prospective
Last update:2023-08-12, 1402/05/21
Update count:0
Registration date
2023-08-12, 1402/05/21
Registrant information
Name
Farnoosh Javadimarand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2249 4967
Email address
farnooshjavadii@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-19, 1402/05/28
Expected recruitment end date
2023-10-20, 1402/07/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the effect of melatonin and zolpidem on the onset and number of sleep hours after laparoscopic abdominal surgery
Public title
Investigating the effect of melatonin and zolpidem on postoperative sleep disturbance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 and 50 years
Anesthesia class ASA1,2
Consent to participate in the study
Male gender
Laparoscopic abdominal surgery
The duration of surgery is less than one hour
Exclusion criteria:
Emergency surgery
Pregnant women or the possibility of pregnancy
Diabetic, cardiac, pulmonary and neurological patients
Having a history of sleep disorders
Age
From 20 years old to 50 years old
Gender
Male
Phase
4
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
168
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants in three groups and the researcher remain unaware of how the type of drug is allocated during the study. The patient is informed that there are three types of drug packages in a study and they will receive one of them randomly. they are similar in packaging and have no difference.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Tehran Islamic Azad University Of Medical Sciences
Street address
Tehran Islamic Azad University of Medical Sciences, Khaghani St, Shariati Ave
City
Tehran
Province
Tehran
Postal code
19499160112
Approval date
2022-12-26, 1401/10/05
Ethics committee reference number
IR.IAU.TMU.REC.1401.327
Health conditions studied
1
Description of health condition studied
Sleep quality after laparoscopic abdominal surgery
ICD-10 code
G47
ICD-10 code description
Sleep disorders
Primary outcomes
1
Description
Sleep duration score based on Pittsburgh sleep quality index questionnaire
Timepoint
Measuring the sleep duration score according to the Pittsburgh sleep quality index questionnaire on the first, second and third nights after surgery
Method of measurement
Patient statements in the Pittsburgh Sleep Quality Index Questionnaire
2
Description
Sleep onset delay score based on the Pittsburgh Sleep Quality Index questionnaire
Timepoint
Measuring sleep onset delay according to the Pittsburgh sleep quality index questionnaire on the first, second and third night after surgery
Method of measurement
Patient statements in the Pittsburgh Sleep Quality Index Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients who undergo laparoscopic abdominal surgery receive 10 mg zolpidem for 3 nights after surgery.
Category
Treatment - Drugs
2
Description
Intervention group: Patients who undergo laparoscopic abdominal surgery receive 6 mg of melatonin orally for 3 nights after surgery.
Category
Treatment - Drugs
3
Description
Control group: Patients who undergo laparoscopic abdominal surgery receive a placebo with the same appearance as the drugs of the intervention group for 3 nights after the surgery.