Protocol summary

Summary
Objective: Comparing the effect of melatonin, clonidine or gabapentin on reducing the preoperative anxiety and postoperative pain in patients undergoing laparoscopic cholecystectomy. Patients referred to Shariati Hospital in 1393 for laparoscopic cholecystectomy who did not did not have a history of congenital heart diseases, heart valve diseases, liver or kidney diseases, psychological disorders, opioid addiction, uncontrolled hypertension, and those without with verbal or communication difficulties will be included in the study. In a randomized double-blind placebo-controlled clinical study, 88 patients undergoing laparoscopic cholecystectomy under general anesthesia will be enrolled and randomly assigned to one of the four study groups: clonidine (C), melatonin (M), gabapentin (G), or placebo (P). 120 minutes before inducing anesthesia, patients will be administered oral clonidine (0.2 mg), melatonin (6 mg), gabapentin (600 mg), or placebo, respectively. In order to alleviate the pain, morphine will be administered using the PCA instrument. Preoperative anxiety, changes in the vital signs after induction of anesthesia, total dosage of the intraoperatively administered opioid, Bispectral index (BIS), morphine dosage within 24 h of the operation, the first time of requesting morphine post-operation, and postoperative nausea and vomiting (PONV) will be recorded and compared for all patients. The level of pain will also be accessed and recorded using a 10-score visual analogue scale (VAS) 1 h, 2 h, 6 h, 12 h, and 24 h after the surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014041217231N1
Registration date: 2014-07-01, 1393/04/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-07-01, 1393/04/10
Registrant information
Name
Vahideh Sadat Hosseini
Name of organization / entity
Shariati hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2373
Email address
hghasemi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-06-01, 1393/03/11
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of melatonin, clonidine or gabapentin on reducing the preoperative anxiety and postoperative pain in patients undergoing laparoscopic cholecystectomy in Shariati Hospital in 1393
Public title
The effect of melatonin, clonidine, and gabapentin on reducing the preoperative anxiety and postoperative pain in patients undergoing laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients scheduled for elective laparoscopy cholecystectomy; Signing the informed written consent; Exclusion Criteria:History of congenital heart diseases; History of heart valve diseases; History of liver or kidney diseases; History of psychological disorders; Opioid addiction; Uncontrolled hypertension; Patients with verbal or communication difficulties
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
research ethics committee - TUMS
Street address
Tehran University of Medical sciences
City
Tehran
Postal code
Approval date
2013-08-04, 1392/05/13
Ethics committee reference number
92/د/130/912

Health conditions studied

1

Description of health condition studied
Epigastric Pain
ICD-10 code
R10.1
ICD-10 code description
Pain localized to upper abdomen

2

Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety NOS

Primary outcomes

1

Description
Anxiety
Timepoint
The night before the surgery and when entering the operating room
Method of measurement
STAI questionnaire

2

Description
Pain
Timepoint
2 h before and 1 h, 2 h, 6 h, 12 h, and 24 h after the surgery
Method of measurement
VAS, PCA

Secondary outcomes

empty

Intervention groups

1

Description
Placebo, 120min before surgery
Category
Placebo

2

Description
melatonin 6mg, 120min before surgery
Category
Treatment - Drugs

3

Description
clonidine 0.2mg, 120min before surgery
Category
Treatment - Drugs

4

Description
Gabapentin 600mg, 120min before surgery
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Vahideh Sadat Hosseini
Street address
Shariati hospital, North kargar st.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masud Yunesian
Street address
Keshavarz Bolvard, Ghods St
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shariati Hospital
Full name of responsible person
Vahideh Sadat Hosseini
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Shariati Hospital, North Kargar st.
City
Tehran
Postal code
Phone
+98 21 8490 1001
Fax
Email
dr.vahideh.hosseini@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shariati Hospital
Full name of responsible person
Vahideh Sadat Hosseini
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Shariati hospital, North Kargar st.
City
Tehran
Postal code
Phone
+98 21 8490 1001
Fax
Email
dr.vahideh.hosseini@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shariati Hospital
Full name of responsible person
Vahideh Sadat Hosseini
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Shariati hospital, North Kargar st.
City
Tehran
Postal code
Phone
+98 21 8490 1001
Fax
Email
dr.vahideh.hosseini@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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