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

• Sponsor: Al-Azhar University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05988671
• Collaborator: Benha University (Other)
• Enrollment: 120
• Locations: 2
• Arms: 4
• Anticipated Duration (Months): 2.2
• Patients Per Site: 60
• Patients Per Site Per Month: 27.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Laparoscopic Cholecystectomy; Postoperative Nausea and Vomiting	Drug: normal Saline; Drug: Dexamethasone; Drug: Dexmedetomidine; Drug: Combination of dexamethasone + dexmedetomidine	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Comparison of Intraperitoneal Dexamethasone, Dexmedetomidine, and Dexamethasone-Dexmedetomidine Combination on Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Randomized Clinical Trial
• Anticipated Study Start Date: Aug 10, 2023
• Anticipated Primary Completion Date: Oct 15, 2023
• Anticipated Study Completion Date: Oct 15, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The number of patients suffered from postoperative nausea and vomiting will be recorded in each group. [24 hours postoperative]

Secondary Outcome Measures

1. antiemetic consumption [24 hours postoperatively]

   frequency of antiemetic consumption will be determined

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Haney Baumey	Banhā		Egypt	13518
2	Neveen Kohaf	Tanta		Egypt	11865

Sponsors and Collaborators

• Al-Azhar University
• Benha University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Neveen Abd El Maksoad Kohaf, Lecturer of Clinical Pharmacy, Al-Azhar University
• ClinicalTrials.gov Identifier: NCT05988671
• Other Study ID Numbers: RC 10-3-2023
• First Posted: Aug 14, 2023
• Last Update Posted: Aug 14, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting; Dexamethasone; Dexamethasone acetate; Dexmedetomidine; BB 1101

Study Results

No Results Posted as of Aug 14, 2023