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Dexamethasone at Night vs at Induction on PONV After Laparoscopic Cholecystectomy

Primary Purpose

Postoperative Nausea and Vomiting, Postoperative Pain, Laparoscopic Cholecystectomy

Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
At-night Dexamethasone
At-induction Dexamethasone
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: all consecutive adults (older than 18 years) with ASA physical status I-III undergoing elective laparoscopic cholecystectomy surgery at gastrointestinal surgery center. Exclusion Criteria: patient refusal use of steroids or antiemetic agents within 1 week of surgery chronic opioid therapy history of allergy to any study medications serum creatinine > 1.4 mg/dl liver enzymes more than triple normal limits pregnancy psychiatric or neurologic diseases or socioeconomic status that would hinder postoperative quality of recovery questionnaire Patients whose laparoscopic surgery is converted to open surgery after enrollment will be excluded.

Sites / Locations

  • Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

At-night dexamethasone

At-induction dexamethasone

Arm Description

Patients in the intervention group will receive intravenous 8 mg dexamethasone at night before surgery. The time of dexamethasone administration will be recorded. The dexamethasone ampule will be diluted in a 10 ml syringe and given in at least one minute to avoid unpleasant sensation in injection.

Patients in the control group will receive intravenous 8 mg dexamethasone just before or at the induction of anesthesia. The dexamethasone ampule will be diluted in a 10 ml syringe and given in at least one minute to avoid unpleasant sensation in injection.

Outcomes

Primary Outcome Measures

postoperative nausea or vomiting (PONV)
incidence of PONV (binary outcome as yes/No)

Secondary Outcome Measures

The need for rescue antiemetic
Dichotomous yes/no outcome
The need for rescue analgesia
Dichotomous yes/no outcome
Postoperative Care Unit (PACU) and Early PONV
Dichotomous yes/no outcome
Late PONV
Dichotomous yes/no outcome
Visual Analogue Scale (VAS)
VAS as a scale 0 - 10
Visual Analogue Scale (VAS)
VAS as a scale 0 - 10
Postoperative quality of recovery (QoR)
QoR-15 questionnaire (doi: https://doi.org/10.1097/ALN.0b013e318289b84b)
Post-Discharge Nausea and Vomiting (PDNV)
evaluated by telephone by Dichotomous yes/no outcome

Full Information

First Posted
August 11, 2023
Last Updated
October 8, 2023
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05998317
Brief Title
Dexamethasone at Night vs at Induction on PONV After Laparoscopic Cholecystectomy
Official Title
Dexamethasone At-induction vs At-night to Prevent Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Protocol for Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 8, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Since the peak effect of the dexamethasone is delayed to 12-16 hours after iv administration, we designed this study to investigate the effect of administering dexamethasone at-night before surgery versus at-induction (the standard timing) in prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy. A pilot randomized controlled study (60 cases) will be started to explore the potential difference, ensure correct and rigorous data collection, and calculate the sample size for a larger pragmatic trial.
Detailed Description
Background: Postoperative nausea and vomiting (PONV) are common complications after laparoscopic cholecystectomy. The aim of this study is to evaluate the efficacy of administration of prophylactic dexamethasone 12-hours prior to induction of anesthesia in preventing PONV after elective laparoscopic cholecystectomy, as it reaches its peak effect at 2-12 hours and lasts for 72 hours after intravenous (iv) administration. Methods: This is a parallel two-arm, randomized (1:1), double-blind, controlled, single-center trial. Adults (≥18 years) with American Society of Anesthesiology (ASA) physical status I-III scheduled for elective laparoscopic cholecystectomy will be eligible for inclusion. The participants will be randomized to receive either 8 mg IV Dexamethasone at time of induction of anesthesia or 8 mg IV Dexamethasone at 12 hours prior to induction of anesthesia. The primary outcome will be the incidence of postoperative nausea and vomiting. A total of 60 patients will be recruited as a pilot study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting, Postoperative Pain, Laparoscopic Cholecystectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized controlled trial superiority parallel trial. This is a pilot trial and the sample size will be updated after the pilot study completion and the approval of the local Institutional Review Board (IRB).
Masking
ParticipantCare ProviderInvestigator
Masking Description
The pharmacists will prepare the study drug, either dexamethasone or saline in 10 mL similar syringes, according to the allocation. The syringe will be labeled with the patient's name and the allocation group, A or B. The study participants, caregivers, data collectors, and data analysts will all be blinded. The pharmacists will not participate in the study.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
At-night dexamethasone
Arm Type
Experimental
Arm Description
Patients in the intervention group will receive intravenous 8 mg dexamethasone at night before surgery. The time of dexamethasone administration will be recorded. The dexamethasone ampule will be diluted in a 10 ml syringe and given in at least one minute to avoid unpleasant sensation in injection.
Arm Title
At-induction dexamethasone
Arm Type
Active Comparator
Arm Description
Patients in the control group will receive intravenous 8 mg dexamethasone just before or at the induction of anesthesia. The dexamethasone ampule will be diluted in a 10 ml syringe and given in at least one minute to avoid unpleasant sensation in injection.
Intervention Type
Drug
Intervention Name(s)
At-night Dexamethasone
Intervention Description
Patients in the intervention group will receive intravenous 8 mg dexamethasone at night before surgery. The time of dexamethasone administration will be recorded. The dexamethasone ampule will be diluted in a 10 ml syringe and given in at least one minute to avoid unpleasant sensation in injection.
Intervention Type
Drug
Intervention Name(s)
At-induction Dexamethasone
Intervention Description
Patients in the control group will receive intravenous 8 mg dexamethasone just before or at the induction of anesthesia. The dexamethasone ampule will be diluted in a 10 ml syringe and given in at least one minute to avoid unpleasant sensation in injection.
Primary Outcome Measure Information:
Title
postoperative nausea or vomiting (PONV)
Description
incidence of PONV (binary outcome as yes/No)
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
The need for rescue antiemetic
Description
Dichotomous yes/no outcome
Time Frame
24 hours after surgery
Title
The need for rescue analgesia
Description
Dichotomous yes/no outcome
Time Frame
24 hours after surgery
Title
Postoperative Care Unit (PACU) and Early PONV
Description
Dichotomous yes/no outcome
Time Frame
within 6 hours after surgery
Title
Late PONV
Description
Dichotomous yes/no outcome
Time Frame
6-24 hours after surgery
Title
Visual Analogue Scale (VAS)
Description
VAS as a scale 0 - 10
Time Frame
at the time of discharge from PACU (usually at 2 hours after surgery)
Title
Visual Analogue Scale (VAS)
Description
VAS as a scale 0 - 10
Time Frame
at the time of discharge from hospital (usually 24 hours after surgery)
Title
Postoperative quality of recovery (QoR)
Description
QoR-15 questionnaire (doi: https://doi.org/10.1097/ALN.0b013e318289b84b)
Time Frame
24 hours after surgery
Title
Post-Discharge Nausea and Vomiting (PDNV)
Description
evaluated by telephone by Dichotomous yes/no outcome
Time Frame
at 72 hours after surgery
Other Pre-specified Outcome Measures:
Title
Surgical Site Infection
Description
infection as defined by the surgeon) at the trocar's or the drainage tube sites.
Time Frame
at follow-up (usually at 7 days after surgery)
Title
Itching or burning sensation
Description
as described by the patient as dichotomous outcome yes/no outcome
Time Frame
during injection of the dexamethasone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all consecutive adults (older than 18 years) with ASA physical status I-III undergoing elective laparoscopic cholecystectomy surgery at gastrointestinal surgery center. Exclusion Criteria: patient refusal use of steroids or antiemetic agents within 1 week of surgery chronic opioid therapy history of allergy to any study medications serum creatinine > 1.4 mg/dl liver enzymes more than triple normal limits pregnancy psychiatric or neurologic diseases or socioeconomic status that would hinder postoperative quality of recovery questionnaire Patients whose laparoscopic surgery is converted to open surgery after enrollment will be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moataz M Emara, MD, EDAIC
Phone
1064048848
Ext
+20
Email
mm.emara@mans.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moataz M Emara, MD, EDAIC
Organizational Affiliation
Mansoura University Faculty of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Medicine
City
Mansoura
State/Province
Aldakahlia
ZIP/Postal Code
35516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moataz M Emara, MD, EDAIC
Phone
+201064048848
Email
mm.emara@mans.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The anonymised data will be available on appropriate response with the prinicipal investigator.
IPD Sharing Time Frame
Within one year of study completion
IPD Sharing Access Criteria
will be notified shortly

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Dexamethasone at Night vs at Induction on PONV After Laparoscopic Cholecystectomy

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