Intraperitoneal Dexamethasone, Dexmedetomidine, and Dexamethasone-Dexmedetomidine Combination on Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
Primary Purpose
Laparoscopic Cholecystectomy, Postoperative Nausea and Vomiting
Status
Not yet recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
normal Saline
Dexamethasone
Dexmedetomidine
Combination of dexamethasone + dexmedetomidine
Sponsored by
About this trial
This is an interventional prevention trial for Laparoscopic Cholecystectomy
Eligibility Criteria
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
Sites / Locations
- Haney Baumey
- Neveen Kohaf
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Control group
dexamethasone group
dexmedetomidine group
combined group
Arm Description
received 20 ml normal saline
received 8mg dexamethasone
received dexmedetomidine 1mic/kg
received combination of both 8mg dexamethasone+ dexmedetomidine 1mic/kg
Outcomes
Primary Outcome Measures
The number of patients suffered from postoperative nausea and vomiting will be recorded in each group.
Secondary Outcome Measures
antiemetic consumption
frequency of antiemetic consumption will be determined
Full Information
NCT ID
NCT05988671
First Posted
August 4, 2023
Last Updated
August 10, 2023
Sponsor
Al-Azhar University
Collaborators
Benha University
1. Study Identification
Unique Protocol Identification Number
NCT05988671
Brief Title
Intraperitoneal Dexamethasone, Dexmedetomidine, and Dexamethasone-Dexmedetomidine Combination on Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
Official Title
Comparison of Intraperitoneal Dexamethasone, Dexmedetomidine, and Dexamethasone-Dexmedetomidine Combination on Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 10, 2023 (Anticipated)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
October 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
Collaborators
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Cholecystectomy, Postoperative Nausea and Vomiting
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
received 20 ml normal saline
Arm Title
dexamethasone group
Arm Type
Active Comparator
Arm Description
received 8mg dexamethasone
Arm Title
dexmedetomidine group
Arm Type
Active Comparator
Arm Description
received dexmedetomidine 1mic/kg
Arm Title
combined group
Arm Type
Active Comparator
Arm Description
received combination of both 8mg dexamethasone+ dexmedetomidine 1mic/kg
Intervention Type
Drug
Intervention Name(s)
normal Saline
Intervention Description
Intraperitoneal route
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Intraperitoneal route
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Intraperitoneal route
Intervention Type
Drug
Intervention Name(s)
Combination of dexamethasone + dexmedetomidine
Intervention Description
Intraperitoneal route
Primary Outcome Measure Information:
Title
The number of patients suffered from postoperative nausea and vomiting will be recorded in each group.
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
antiemetic consumption
Description
frequency of antiemetic consumption will be determined
Time Frame
24 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Haney Baumey
City
Banhā
ZIP/Postal Code
13518
Country
Egypt
Facility Name
Neveen Kohaf
City
Tanta
ZIP/Postal Code
11865
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neveen Kohaf
Phone
+201060383012
Email
nevenabdo@azhar.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
data could be shared upon reasonable request from principal investigator
Learn more about this trial
Intraperitoneal Dexamethasone, Dexmedetomidine, and Dexamethasone-Dexmedetomidine Combination on Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy
We'll reach out to this number within 24 hrs