Protocol summary

Summary
The purpose of this study was to compare the effect of intravenous ketamine and metochlopramid before induction of anesthesia on postoperative pain and analgesic requirements. In this double blind clinical trial, 86 ASA1, 2 patients who were candidates for lower abdominal surgery, were enrolled. The patients with severe bleeding and those who needed blood transfusion were excluded. The eligible patients were randomly assigned to receive metoclopramide, 10 mg, or ketamine, 0.3 mg/kg, intravenously before induction of anesthesia. Score of pain, amount of opioid consumption in recovery and first 24 hours, and postoperative complications such as nausea and vomiting, postoperative ondansetron consumption, irritability, and psychological problems record were measured and compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201011054819N1
Registration date: 2010-12-22, 1389/10/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-12-22, 1389/10/01
Registrant information
Name
Saied Morteza Heidari Tabaei Zavareh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1267 6415
Email address
m_heidari@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2008-04-20, 1387/02/01
Expected recruitment end date
2008-07-22, 1387/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison study of metoclopramide and ketamine on postoperative nausea and vomiting
Public title
Effect of metoclopramide on postoperative nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 18-65 years old male and female patients with ASA1-2, no hypersensitivity to Ketamine or Metochlopramide who are candidates for elective laparotomy surgery under general anesthesia Exclusion criteria: severe bleeding during anesthesia and need to blood transfusion during surgery
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 86
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Hezarjerib street, Isfahan
City
Isfahan
Postal code
Approval date
2009-02-01, 1387/11/13
Ethics committee reference number
387361

Health conditions studied

1

Description of health condition studied
postopertive pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
postoperative pain
Timepoint
At 30th and 60th minutes at the recovery room and 2, 4, 6, and 24 hours postoperatively
Method of measurement
visual anlogue scale (VAS)

Secondary outcomes

1

Description
recovery stay time
Timepoint
end of recovery stay
Method of measurement
in minutes

2

Description
amounts of opoid consumption
Timepoint
At the recovery room and over 24 hours postoperatively
Method of measurement
in mg

3

Description
amounts of ondansetron consumption
Timepoint
Over 24 hours postoperatively
Method of measurement
in mg

4

Description
postoperative nausea and vomiting
Timepoint
At the recovery room and 6, 12, and 24 hours postoperatively
Method of measurement
observation and VAS

5

Description
irritability
Timepoint
at recovery room
Method of measurement
observation

6

Description
psychologic problems
Timepoint
at recovery
Method of measurement
observation

Intervention groups

1

Description
Metoclopramide, 10 mg, intravenously, 30 minutes before induction of anesthesia
Category
Treatment - Drugs

2

Description
Ketamine, 0.3 mg/kg, intravenously, 30 minutes before induction of anesthesia
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital of Isfahan, Iran
Full name of responsible person
Saied Morteza Heidari
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Saied Morteza Heidari
Street address
Department of anesthesia, Alzahra Hospital, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Jamshid Salehi
Position
General Practitioner
Other areas of specialty/work
Street address
Alzahra hospital, Hezar jerib Street, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1668 5555
Fax
Email
m_heidari@med.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Saied Morteza Heidari
Position
associated professor
Other areas of specialty/work
Street address
Alzahra hospital, Hezar Jerib Street, Isfahan, Iran
City
Isfahan
Postal code
00983116685555
Phone
+98 311668555
Fax
Email
m_heidari@mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Hamid Saryazdi
Position
Assistant Professor
Other areas of specialty/work
Street address
Alzahra Hospital
City
Isfahan
Postal code
Phone
Fax
Email
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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