Intraperitoneal Dexamethasone, Dexmedetomidine, and Dexamethasone-Dexmedetomidine Combination on Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

February 5, 2024 updated by: Neveen Abd El Maksoad Kohaf, Al-Azhar University

Comparison of Intraperitoneal Dexamethasone, Dexmedetomidine, and Dexamethasone-Dexmedetomidine Combination on Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Randomized Clinical Trial

Nausea and vomiting are some of the most common complaints of patients after any anesthesia, which is often associated with postop-erative pain. The double-blind clinical trial study aimed to compare the prophylactic effect of dexamethasone and dexmedetomidine and their combination in reducing postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Banhā, Egypt, 13518
        • Recruiting
        • Haney Baumey
        • Sub-Investigator:
          • Haney Baumey, M.D
        • Sub-Investigator:
          • Ahmed Abo Sakaya, M.D
        • Sub-Investigator:
          • Mohamed Elmeligy, M.D
        • Contact:
      • Tanta, Egypt, 11865

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged from 20 - 50 years
  • ASA I OR II
  • undergo laparoscopic cholecystectomy

Exclusion Criteria:

  • Patients with history of psychotic illnesses,
  • Parkinson's disease
  • motion disorder
  • Smoker
  • or history of chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
received 20 ml normal saline
Drug: normal Saline
Intraperitoneal route
Active Comparator: dexamethasone group
received 8mg dexamethasone
Drug: Dexamethasone
Intraperitoneal route
Active Comparator: dexmedetomidine group
received dexmedetomidine 1mic/kg
Drug: Dexmedetomidine
Intraperitoneal route
Active Comparator: combined group
received combination of both 8mg dexamethasone+ dexmedetomidine 1mic/kg
Drug: Combination of dexamethasone + dexmedetomidine
Intraperitoneal route

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of patients suffered from postoperative nausea and vomiting will be recorded in each group.
Time Frame: 24 hours postoperative
24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
antiemetic consumption
Time Frame: 24 hours postoperatively
frequency of antiemetic consumption will be determined
24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Collaborators

Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2023

Primary Completion (Estimated)

March 30, 2024

Study Completion (Estimated)

March 30, 2024

Study Registration Dates

First Submitted

August 4, 2023

First Submitted That Met QC Criteria

August 10, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC 10-3-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

data could be shared upon reasonable request from principal investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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