ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12614000703606

Ethics application status

Approved

Date submitted

18/06/2014

Date registered

3/07/2014

Date last updated

3/07/2014

Type of registration

Retrospectively registered

Titles & IDs

Public title

Effectiveness of sub hypnotic propofol and dexamethasone in preventing postoperative nausea and vomiting after laparoscopic cholecystectomy.

Scientific title

Effectiveness of sub hypnotic propofol and dexamethasone in preventing postoperative nausea and vomiting after laparoscopic cholecystectomy

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

postoperative nausea and vomiting following laparoscopic cholecystectomy

Condition category

Condition code

Anaesthesiology

Anaesthetics

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A total of 120 ASA physical status I and II were included in this randomized, double-blind, placebo-controlled study. Patients were randomly assigned to 3 groups (n=40) before induction of anesthesia. Patients of group dexamethasone (group D) were administrated 8 mg dexamethasone intravenous infusion before induction of anesthesia. Patients of group propofol (group P) were infused to sub hypnotic (1 mg/kg/h) propofol during operation. Patients of group control (group C) were applied infusion of 10% intralipid until the end of surgery. The incidence of PONV, needs for rescue analgesic and antiemetic were recorded in the first 24 h postoperatively.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Group P and group C received isotonic saline solution in 2 ml before induction of anesthesia. Patients of group control (group C) were applied infusion of 10% intralipid until the end of surgery.

Control group

Placebo

Outcomes

Primary outcome [1]

The primary aim of this prospective, randomized, double blind, placebo-controlled study was to evaluate the efficacy of dexamethasone and continuous infusion of sub hypnotic propofol to prevent PONV in patients undergoing laparoscopic cholecystectomy.PONV will be assessed using a four-point ordinal scale (0=none, 1=nausea, 2=nausea with request for antiemetic, 3=vomiting)

Timepoint [1]

first 24 hours after operation

Secondary outcome [1]

Secondary aim of this study was to determine the rescue antiemetic and analgesic in the first 24 hours after laparoscopic cholecystectomy

Timepoint [1]

in the first 24 hours after laparoscopic cholecystectomy

Eligibility

Key inclusion criteria

18- 65 years female and male
ASA I-II
patients undergoing laparoscopic cholecystectomy

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

pregnancy
use of antiemetic drug 24 hours before LC
a history of vomiting and nausea in the previous operations susceptibility to nausea and vomiting
menstruation
emergency operation
severe diabetes mellitus
conversion from LC to an laparotomy procedure

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

numbered containers

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

computerised sequence generation

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

Before study, sample size was determined by power analysis, assuming that the total incidence of PONV in the placebo group would be 70%, with a 35% reduction in the incidence of PONV in the treatment group with alpha error was set at 0.05 and beta error at 0.2. According to power analysis, any group size of 31 patients was considered adequate. We decided to enroll 40 patients per group to allow dropout. The post-hoc test which was held during the statistical evaluation showed 31 patients for the propofol group and 35 patients for the dexamethasone group were needed. Statistical analysis was performed using the program of SPSS20. One way ANOVA was used to compare the differences of numeric data among the groups. Chi-squared test was used for categorical data. Level of significance was set at p < 0.05.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

26/12/2013

Actual

1/01/2014

Date of last participant enrolment

Anticipated

1/06/2014

Actual

10/06/2014

Date of last data collection

Anticipated

Actual

Sample size

Target

120

Accrual to date

Final

Recruitment outside Australia

Country [1]

Turkey

State/province [1]

Erzurum

Funding & Sponsors

Funding source category [1]

University

Name [1]

Ataturk University

Address [1]

Department of Anaesthesiology and Reanimation,
Faculty of Medicine, Ataturk University, Erzurum, Turkey
Postal code: 25240

Country [1]

Turkey

Primary sponsor type

University

Name

Ataturk University

Address

Department of Anaesthesiology and Reanimation,
Faculty of Medicine, Ataturk University, Erzurum, Turkey
Postal code: 25240

Country

Turkey

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethical committee of Ataturk University Medical Faculty

Ethics committee address [1]

Vaniefendi district, Ataturk University Medical Faculty , Erzurum,Turkey
postal code:25240

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

01/12/2013

Approval date [1]

26/12/2013

Ethics approval number [1]

Date: 26.12.2013/ Number:2

Summary

Brief summary

Postoperative nausea and vomiting (PONV) are distressful common side-effects following laparoscopic cholecystectomy (LC) .The reported incidence of PONV is 46–72% in patients undergoing LC if prophylactic antiemetic is not given 
As an anesthetic agent, propofol is highly effective drug preventing postoperative nausea and vomiting , thus it has been used by a number of anesthesiologist.It was demonstrated that continuous infusion of sub hypnotic propofol prevents PONV in female patients receiving intravenous patient-controlled analgesia .
Glucocorticoids have analgesic, anti-inflammatory, immune-modulating and antiemetic effects. But, their effect mechanisms are not fully clarified . Dexamethasone, as an glucocorticoid, has been used as an antiemetic drug in patients receiving chemotherapy for more than 25 years .Several prospective studies have shown that severity of PONV associated with LC is reduced by dexamethasone.
The primary aim of this prospective, randomized, double blind, placebo-controlled study was to evaluate the efficacy of dexamethasone and continuous infusion of sub hypnotic propofol to prevent PONV in patients undergoing LC. Secondary aim of this study was to determine the rescue antiemetic and analgesic in the first 24 hours after LC.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/366565-manuscript.docx

Contacts

Principal investigator

Name

Dr Mine Celik

Address

Ataturk university Medical Faculty Department of Anesthesiology and Reanimation 25240 Palandoken/ERZURUM

Country

Turkey

Phone

+904423447929

Fax

mine.celik74@gmail.com

Contact person for public queries

Name

Hulya Aksoy

Address

Vaniefendi district, Ethical committee of Ataturk University Medical Faculty , Erzurum,Turkey, postal code:25240

Country

Turkey

Phone

+905074416869

Fax

aksoyhulya@yahoo.com

Contact person for scientific queries

Name

Haci Ahmet Alici

Address

Department of Anaesthesiology and Reanimation,
Faculty of Medicine, Ataturk University, Erzurum, Turkey
Postal code: 25240

Country

Turkey

Phone

+904423447052

Fax

haalici@atauni.edu.tr

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Is infusion of subhypnotic propofol as effective as dexamethasone in prevention of postoperative nausea and vomiting related to laparoscopic cholecystectomy? A randomized controlled trial.	2015	https://dx.doi.org/10.1155/2015/349806

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

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