Protocol summary

Summary
Introduction: Reduction of post operative nausea and vomiting accelerates discharge of patients and reduces healthcare costs, hospital re–admission and duration of hospitalization, and increases satisfaction of patients. Methods: This study was an interventional experiment performed on 180 patients undergoing GLS. Patients were selected from those who referred to afzalipoor hospital of Kerman for diagnostic GLS and were aged 18-35 with ASA I or II. This study was approved by the hospital ethics research committee [Code: EC/KNRC/88-169] and registered with the European Clinical Trials Database. Exclusion criteria included: diabetes, addiction to drugs, history of nausea or vomiting and or using drugs with known anti-emetic properties (like metformin, clomifen, medroxy progestron, bromocriptin) 24 hours before the surgery, smoking, motion disease history, previous experience of PONV, surgical duration more than 45 minutes, usage of opioids after surgery in recovery period and weight more than 70kg. They were randomly allocated to three groups: alfentanil, sufentanil and fentanyl. After entrance of the patient to the OR, alfentanil 2cc (1000μg); fentanil 2cc (100μg); sufentanil 2cc (10μg) was administered to the three group of patients two minutes before I.V. induction of anesthesia to the patient. After surgery and extubation and entrance into recovery ward, incidence of nausea or vomiting was recorded from the entrance to the ward until 24 hours after surgery in the check list by a resident of anesthesiology who was blinded to the drug administered to the patient.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138810293104N1
Registration date: 2012-08-24, 1391/06/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-08-24, 1391/06/03
Registrant information
Name
Mohammad Shabani
Name of organization / entity
Kerman Neuroscience Research Center
Country
Iran (Islamic Republic of)
Phone
+98 34 1226 4196
Email address
shabani@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2010-03-20, 1388/12/29
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of fentanyl, sufentanil and alfentanil as premedication on postoperative nausea and vomiting in diagnostic gynecologic laparascopy in hundred eighty patients (ASA I and II), aged 18-35 year
Public title
Comparison the effects of fentanyl, sufentanil and alfentanil as premedication on postoperative nausea and vomiting in diagnostic gynecologic laparascopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients were selected from those who referred to afzalipoor hospital of Kerman for diagnostic GLS and were aged 18-35 with ASA I or II. Exclusion criteria: diabetes mellitus; addiction to drugs; history of nausea or vomiting and or using drugs with known anti-emetic properties (like metformin, clomifen, medroxy progestron, bromocriptin) 24 hours before the surgery; smoking; motion disease history; previous experience of PONV; surgical duration more than 45 minutes; usage of opioids after surgery in recovery period and weight more than 70kg. After signing informed consent by all the patients, 180 subjects were enrolled in the study.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 180
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
Kerman University of Medical Sciences Ethics Committee
Street address
Somayeh crossroad- Kerman Neuroscience Research Center
City
Kerman
Postal code
Approval date
2009-04-21, 1388/02/01
Ethics committee reference number
172/89/کا

Health conditions studied

1

Description of health condition studied
gynecologic
ICD-10 code
N80-N98
ICD-10 code description
N80-N98

Primary outcomes

1

Description
Vomitting
Timepoint
0-24, 0-2, 2-24(0-24 hours after surgury)
Method of measurement
Observation

2

Description
Nausea
Timepoint
0-24, 0-2, 2-24(0-24 hours after surgury)
Method of measurement
Observation

Secondary outcomes

empty

Intervention groups

1

Description
Midazolam 1mg and alfentanil 2cc (1000μg). Induction of every three group was performed using thiopental (5mg/kg) and succynyl choline (1.5mg/kg), anesthesia was maintained using isoflurane 1.2% gas and a mixture of N2O-O2 with 50/50 ratio. Due to the short duration of surgery, there was no need to repeat administration of opioid drug and in the case of surgery lasting more than 45 minutes and repetition of opioid administration, patient was excluded from the study.
Category
Treatment - Drugs

2

Description
Midazolam 1mg and fentanil 2cc (100μg); was administered to the patients two minutes before I.V. induction of anesthesia to the patient (each 1cc of the three drugs has equal power). Induction of every three group was performed using thiopental (5mg/kg) and succynyl choline (1.5mg/kg), anesthesia was maintained using isoflurane 1.2% gas and a mixture of N2O-O2 with 50/50 ratio. Due to the short duration of surgery, there was no need to repeat administration of opioid drug and in the case of surgery lasting more than 45 minutes and repetition of opioid administration, patient was excluded from the study.
Category
Treatment - Drugs

3

Description
Midazolam 1mg and sufentanil 2cc (10μg) was administered to the patients two minutes before I.V. induction of anesthesia to the patient (each 1cc of the three drugs has equal power). Induction of every three group was performed using thiopental (5mg/kg) and succynyl choline (1.5mg/kg), anesthesia was maintained using isoflurane 1.2% gas and a mixture of N2O-O2 with 50/50 ratio. Due to the short duration of surgery, there was no need to repeat administration of opioid drug and in the case of surgery lasting more than 45 minutes and repetition of opioid administration, patient was excluded from the study.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Street address
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy research and tecnology in kerman medical university
Full name of responsible person
dr taravati
Street address
kerman medical university
City
kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy research and tecnology in kerman medical university
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
Kerman Neuroscience Research Center
Full name of responsible person
Mohammad Shabani
Position
PhD
Other areas of specialty/work
Street address
Kerman
City
Kerman
Postal code
Phone
+98 34 1226 4198
Fax
Email
shabanimoh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Neuroscience Research Center- kerman medical university
Full name of responsible person
Mohammad Shabani
Position
PhD
Other areas of specialty/work
Street address
Neuroscience Research Center- kerman medical universi
City
Kerman
Postal code
Phone
+98 34 1226 4196
Fax
Email
shabani@kmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
kerman medical university
Full name of responsible person
mohammad shabani
Position
PhD
Other areas of specialty/work
Street address
kerman neuroscience research center
City
kerman
Postal code
Phone
+34 12264196
Fax
Email
shabanimoh@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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