Protocol summary

Summary
This study is aimed to compare the effect of acupressure method with treatment induced by Ondansetron and Metoclopramide on the postoperative nausea and vomiting after strabismus surgery. Two hundred patients, ASA physical status I or II, aged between 10 and 60 years, undergoing strabismus surgery in Farabi Hospital during 2007 to 2008, were included in this randomized, prospective, double-blind and placebo-controlled study. Patients were randomized into four groups of 50 each, using a table of random numbers. Group II patients received Metoclopramide, 0.2 mg/kg, IV just before induction. Group III patients received Ondansetron, 0.15 mg/kg, IV just before induction. In Group IV patients, acupressure bands were applied at the P6 point on both forearms 30 min before induction of anesthesia and removed after 6 hours. In Groups I, II and III, the spherical beads of the acupressure wrist bands were placed inappropriately on the posterior surface of both forearms 30 min prior to induction of anesthesia. Groups I and IV patients received normal saline 1 ml, IV just before induction of anesthesia to maintain blinding. Patients were followed up at the recovery (0-2 hr) and in the ward (2-24 hr) during first 24 hours and were assessed for PONV. Postoperative retching, nausea, and vomiting were recorded by nursing staff who were unaware of the type of treatment given to the patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138807152556N1
Registration date: 2009-12-12, 1388/09/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-12-12, 1388/09/21
Registrant information
Name
Sirus Momenzadeh
Name of organization / entity
Shahid Beheshti University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 7755 8081
Email address
momenzadeh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences and Health Services, personal budget
Expected recruitment start date
2007-04-21, 1386/02/01
Expected recruitment end date
2007-11-06, 1386/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of three methods of acupressure, using Ondansetron and Metoclopramide on the incidance of postoperative nausea and vomiting after strabismus surgery
Public title
Comparison of three methods of acupressure, using Ondansetron and Metoclopramide on the incidance of postoperative nausea and vomiting after strabismus surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: ASA physical status I or II, age 10-60 years old, signing consent to participate in the study Exclusion criteria: Presence of nausea or vomiting during one week prior to the study, local infection near the acupressure point, symptomatic medical illness, travel sickness, recovery more than 2 hours, receiving any medical therapy immediately before surgery
Age
From 10 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 200
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
Tehran University of Medical Sciences and Health Services
Street address
Poorsina Ave.
City
Tehran
Postal code
Approval date
2006-03-17, 1384/12/26
Ethics committee reference number
631

Health conditions studied

1

Description of health condition studied
Strabismus surgery
ICD-10 code
H50
ICD-10 code description
Strabismus

Primary outcomes

1

Description
Nausea & Vomiting
Timepoint
At 0-2 hours at the recovery room and the first 24 hours in the ward
Method of measurement
Question from the patient

Secondary outcomes

empty

Intervention groups

1

Description
Metoclopramide, 0.2 mg/kg, IV, just before induction, at the recovery room (0-2 hr) and in the ward (2-24 hr) during the first 24 hours
Category
Treatment - Drugs

2

Description
Ondansetron, 0.15 mg/kg, IV, just before induction, at the recovery room(0-2 hr) and in the ward (2-24 hr) during the first 24 hours
Category
Treatment - Drugs

3

Description
Acupressure Bands were applied at the P6 point on both forearms 30 min before induction of anesthesia and were removed after 6 hours. at the recovery room(0-2 hr) and in the ward (2-24 hr) during the first 24 hours
Category
Treatment - Other

4

Description
Placebo, Normal Saline 1 ml, IV just before induction , at the recovery room(0-2 hr) and in the ward (2-24 hr) during the first 24 hours
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Farabi Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Hossein Mohammadinasab
Street address
Poorsina Ave.
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 and Health Services
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
University of Medical Sciences and Health Services, Tehran
Full name of responsible person
Hossein Mohammadinasab
Position
Anesthesiologist
Other areas of specialty/work
Street address
Poorsina Ave.
City
Tehran
Postal code
Phone
+98 21 4405 6051
Fax
Email
dr_mohammadinasab@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Farabi Hospital
Full name of responsible person
Hossein Mohammadinasab
Position
Anesthesiologist
Other areas of specialty/work
Street address
Poorsina Ave.
City
Tehran
Postal code
Phone
+98 21 4405 6051
Fax
Email
dr_mohammadinasab@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Farabi Hospital
Full name of responsible person
Hossein Mohammadinasab
Position
Anesthesiologist
Other areas of specialty/work
Street address
Poorsina-Ave.
City
Tehran
Postal code
Iran
Phone
+98 21 4405 6051
Fax
+98 21 4405 6051
Email
dr_mohammadinasab@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
Loading...