Trial Review

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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] 284832 0
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 292219 0
Condition category
Condition code
Anaesthesiology 292555 292555 0 0
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] 289624 0
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] 292415 0
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] 292415 0
first 24 hours after operation
Secondary outcome [1] 308898 0
Secondary aim of this study was to determine the rescue antiemetic and analgesic in the first 24 hours after laparoscopic cholecystectomy
Timepoint [1] 308898 0
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?
No
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] 6158 0
Turkey
State/province [1] 6158 0
Erzurum

Funding & Sponsors
Funding source category [1] 289439 0
University
Name [1] 289439 0
Ataturk University
Country [1] 289439 0
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] 288129 0
None
Name [1] 288129 0
None
Address [1] 288129 0
None
Country [1] 288129 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291198 0
Ethical committee of Ataturk University Medical Faculty
Ethics committee address [1] 291198 0
Vaniefendi district, Ataturk University Medical Faculty , Erzurum,Turkey
postal code:25240
Ethics committee country [1] 291198 0
Turkey
Date submitted for ethics approval [1] 291198 0
01/12/2013
Approval date [1] 291198 0
26/12/2013
Ethics approval number [1] 291198 0
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] 93 93 0 0
/AnzctrAttachments/366565-manuscript.docx

Contacts
Principal investigator
Name 49318 0
Dr Mine Celik
Address 49318 0
Ataturk university Medical Faculty Department of Anesthesiology and Reanimation 25240 Palandoken/ERZURUM
Country 49318 0
Turkey
Phone 49318 0
+904423447929
Fax 49318 0
Email 49318 0
[email protected]
Contact person for public queries
Name 49319 0
Prof Hulya Aksoy
Address 49319 0
Vaniefendi district, Ethical committee of Ataturk University Medical Faculty , Erzurum,Turkey, postal code:25240
Country 49319 0
Turkey
Phone 49319 0
+905074416869
Fax 49319 0
Email 49319 0
[email protected]
Contact person for scientific queries
Name 49320 0
Prof Haci Ahmet Alici
Address 49320 0
Department of Anaesthesiology and Reanimation,
Faculty of Medicine, Ataturk University, Erzurum, Turkey
Postal code: 25240
Country 49320 0
Turkey
Phone 49320 0
+904423447052
Fax 49320 0
Email 49320 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseIs infusion of subhypnotic propofol as effective as dexamethasone in prevention of postoperative nausea and vomiting related to laparoscopic cholecystectomy? A randomized controlled trial.2015https://dx.doi.org/10.1155/2015/349806
N.B. These documents automatically identified may not have been verified by the study sponsor.