Protocol summary

Summary
In thisl study,80 patients,aged 35-60 , class I, II America Society of Anesthesiology, candidate for elective laparoscopic cholecystectomy, randomly divided into 2 equal 40 patients. Patients with a history of seizures and psychiatric disorders are excluded. The patients receive Gabapentin 600 mg in intervention group and capsule without Gabapentin ,empty capsule, orally as a placebo in control group 1.5 hours before surgery. Anesthetic premedication included midazolam( 0.01-0.03 mg/kg), fentanyl (3µg/kg), morphine( 0.1mg/kg), dexamethasone( 8mg), metoclopramide(10 mg) and lidocaine (1mg/kg) l. Anesthesia induced with Sodium thiopental (5mg/kg) and atracurium (0.5mg/kg). Anesthesia is maintained with Isoflurane0.6-1.2% and N2O 50% plus O2 50%.All patients receive intravenous meperidine( 25 mg) after gallbladder removal. The patients are reversed with 2.5mg Neostigmine and 1mg Atropine. The Pain score evaluate with Visual Analog Scale (0-10) every 2 hour for 12 hours then every 6 hour for next 12 hours. If the pain scores greater than 4, Intravenous Morphine( 3 mg ) is administrated. All patients evaluate for nausea and vomiting, vertigo and drowsiness for 24 hours. Finally,we compare Morphine consumption and patient’s pain scores of two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201203107752N3
Registration date: 2012-05-19, 1391/02/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-05-19, 1391/02/30
Registrant information
Name
Parviz Amri Maleh
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 8296
Email address
pamrimaleh@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor of research of Babol Medical Sciences
Expected recruitment start date
2012-02-28, 1390/12/09
Expected recruitment end date
2012-07-30, 1391/05/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Gabapentin on postoperative pain after laparoscopic cholecystectomy
Public title
Effects of Gabapentin on postoperative pain after laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Class I,II, America Society of Anesthesiology;35-60years; Elective Laparoscopic cholecystectomy . Exclusion criteria :History of epilepsy; Psychological disorder ; History of anticonvulsant drug usage; laparotomy during laparoscope surgery; surgery time longer than 3 hours; opioid addiction; Bleeding during surgery that needs blood transfusion.
Age
From 35 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
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
Vice-chancellor of research of Babol University of Medical Sciences
Street address
Gangafrooz St, Babol University of Medical Sciences
City
Babol
Postal code
4717641367
Approval date
2012-02-28, 1390/12/09
Ethics committee reference number
30/5895/23/ژ/پ

Health conditions studied

1

Description of health condition studied
Cholecystectomy
ICD-10 code
Acquired a
ICD-10 code description
Z90.4

Primary outcomes

1

Description
Postoperative paine
Timepoint
72 hours postoperative
Method of measurement
Visual Analog Scale

2

Description
The amount of Morphine
Timepoint
72 hours postoperative
Method of measurement
miligram

Secondary outcomes

1

Description
Sedation
Timepoint
72 h postoperative
Method of measurement
Ramsay sedation scale

2

Description
Nausea and vomiting
Timepoint
72 h postoperative
Method of measurement
Yes/ No

3

Description
Vertigo
Timepoint
72 h postoperative
Method of measurement
Yes/ No

Intervention groups

1

Description
Intervention: Gabapentin 600 mg per oral 1.5 hours before surgery .
Category
Treatment - Drugs

2

Description
In control group : placebo ( capsule without gabapentin ) 1.5 hours before surgery
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shaid Beheshti Hospital
Full name of responsible person
Nikbakhsh, Novin
Street address
Ganafrooz St, Shahid Behshti Hospital
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor of research of Babol University of Medical Sciences
Full name of responsible person
Mostafazadeh, Amrolah
Street address
Gangafrooz St, Babol University of Medical sciences
City
Babol
Grant name
Grant code / Reference number
9032439
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor of research of Babol 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
Babol University of Medical Sciences
Full name of responsible person
Amrimaleh, Parviz
Position
Anestesiologist,FCCM
Other areas of specialty/work
Street address
Gngafrooz,Babol Universcity of Medical Sciences
City
Babol
Postal code
4717641367
Phone
+98 11 1223 8296
Fax
Email
pamrimaleh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol university of Medical Sciences
Full name of responsible person
Amrimaleh, Parviz
Position
Anestesiologist,FCCM
Other areas of specialty/work
Street address
Gangafrooz St,Babol university of Medical Sciences
City
Babol
Postal code
47176
Phone
+98 11 1223 8296
Fax
Email
pamrimaleh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Amrimaleh, Parviz
Position
Anestesiologist,FCCM
Other areas of specialty/work
Street address
Gangafrooz St, Babol University of Medical Sciences
City
Babol
Postal code
4717641367
Phone
+98 11 1219 9591
Fax
Email
pamrimaleh@yahoo.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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