Protocol summary

Study aim
This study was designed to compare the effect of two methods of anesthesia (total intravenous anesthesia with propofol and inhalational anesthesia with isoflurane) on postoperative nausea and vomiting in patients undergoing elective laparoscopy.
Design
Randomized, single-blinded, parallel, clinical trial, phase 3
Settings and conduct
Randomization on an individual level using 4 number blocks created in excel software. Allocation concealment has been carried out. Given the patient's anesthesia after receiving the induction which is identical in both groups, the patient is blind to the type of anesthesia, due to the apparent difference between the two types of anesthesia (inhaler jet mask and intravenous injections). Anesthesiologist (PI) and researcher are not blind to the type of anesthesia and the study is conducted in a single-blinded manner. Data collectors and data analysts have also been blinded. This is study was conducted in Imam Khomeini Hospital Complex. The incidence and severity of nausea and vomiting was evaluated and recorded at 0, 6, 12, and 24 hours after the surgery.
Participants/Inclusion and exclusion criteria
All patients aged 18-65, with ASA class I and II who underwent elective laparoscopy, were included. In the case of emergency surgery, the history of motion sickness or PONV, Positive drug Allergy history, use of anti-emetic drug or unwillingness of the patient, the case was excluded.
Intervention groups
. In the inhalation group, Isoflurane %1.5-1.7 in combination with 1cc Fentanyl and 1cc Atracurium were used every 45-60 minutes during the operation. In the intravenous group, 50cc of Propofol 1% was combined with 1-2cc of Remifentanil and was intravenously infused at the speed of 15-20cc/hr
Main outcome variables
Postoperative nausea and severity in 0, 2, 6, 12, 24 hours after surgery Postoperative vomiting and severity at 0, 2, 6, 12, 24 hours after surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190904044685N2
Registration date: 2019-10-12, 1398/07/20
Registration timing: retrospective

Last update: 2019-10-12, 1398/07/20
Update count: 0
Registration date
2019-10-12, 1398/07/20
Registrant information
Name
kasra karvandian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2620 0287
Email address
k.karvandian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
2019-01-20, 1397/10/30
Actual recruitment end date
2019-05-20, 1398/02/30
Trial completion date
2019-07-23, 1398/05/01
Scientific title
Comparison of Postoperative Nausea and Vomiting (PONV) with Total Intravenous Anesthesia (TIVA) versus Inhalational Anesthesia in patients undergoing Elective Laparoscopy in Imam Khomeini Hospital Complex-Tehran (IKHC)
Public title
Postoperative nausea and vomiting in patients undergoing elective laparoscopy; comparison of total intravenous anesthesia versus inhalational anesthesia; a randomized clinical trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
ASA class I ASA class II Elective laparoscopy
Exclusion criteria:
History of motion sickness History of PONV Positive drug Allergy history Unwillingness of the patient
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 100
Actual sample size reached: 122
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization on an individual level using 4 number blocks created in excel software. Allocation concealment has been carried out.
Blinding (investigator's opinion)
Single blinded
Blinding description
Given the patient's anesthesia after receiving the induction which is identical in both groups, the patient is blind to the type of anesthesia, due to the apparent difference between the two types of anesthesia (inhaler jet mask and intravenous injections). Anesthesiologist (PI) and researcher are not blind to the type of anesthesia and the study is conducted in a single-blinded manner. Data collectors and data analysts have also been blinded.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Imam Khomeini Hospital Complex - Tehran University of Medical Sciences
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2018-07-03, 1397/04/12
Ethics committee reference number
IR.TUMS.IKHC.REC.1397.075

Health conditions studied

1

Description of health condition studied
Postoperative nausea and vomiting
ICD-10 code
K91.0
ICD-10 code description
Vomiting following gastrointestinal surgery

Primary outcomes

1

Description
Incidence and severity of postoperative nausea and vomiting
Timepoint
0, 2, 6, 12, 24 hours after surgery
Method of measurement
Standardized questionnaire, Verbal/Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Total intravenous anesthesia. In the intravenous group, 50cc of Propofol 1% was combined with 1-2cc of Remifentanil and was intravenously infused at the speed of 15-20cc/hr. Depending on patients’ needs and duration of the surgery, the dosage altered to ¬±5cc.
Category
Treatment - Drugs

2

Description
Control group: Inhalational anesthesia. In the inhalation group, Isoflurane %1.5-1.7 in combination with 1cc Fentanyl and 1cc Atracurium were used every 45-60 minutes during the operation.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Kasra Karvandian
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2619
Email
karvandian@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ahmad Esmaillzadeh
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733131
Phone
+98 21 8889 6694
Email
vcr@tums.ac.ir
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kasra Karvandian
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2619
Email
karvandian@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kasra Karvandian
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2619
Email
karvandian@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kasra Karvandian
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2619
Email
karvandian@tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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