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

NCT ID: NCT05988671

Last Updated: 2025-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-10

Study Completion Date

2024-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Laparoscopic Cholecystectomy Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control group

received 20 ml normal saline

Group Type PLACEBO_COMPARATOR

normal Saline

Intervention Type DRUG

Intraperitoneal route

dexamethasone group

received 8mg dexamethasone

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Intraperitoneal route

dexmedetomidine group

received dexmedetomidine 1mic/kg

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Intraperitoneal route

combined group

received combination of both 8mg dexamethasone+ dexmedetomidine 1mic/kg

Group Type ACTIVE_COMPARATOR

Combination of dexamethasone + dexmedetomidine

Intervention Type DRUG

Intraperitoneal route

Interventions

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normal Saline

Intraperitoneal route

Intervention Type DRUG

Dexamethasone

Intraperitoneal route

Intervention Type DRUG

Dexmedetomidine

Intraperitoneal route

Intervention Type DRUG

Combination of dexamethasone + dexmedetomidine

Intraperitoneal route

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role collaborator

Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Neveen Abd El Maksoad Kohaf

Lecturer of Clinical Pharmacy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Haney Baumey

Banhā, , Egypt

Site Status

Neveen Kohaf

Tanta, , Egypt

Site Status

Countries

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Egypt

References

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Bauiomy H, Kohaf NA, Saad M, Rashed ZF, Abosakaya AM. Study the Effect of Intraperitoneal Dexamethasone, Dexmedetomidine, and Their Combination on PONV After Laparoscopic Cholecystectomy: A Randomized Triple-Blind Trial. Anesthesiol Res Pract. 2025 Feb 24;2025:4976637. doi: 10.1155/anrp/4976637. eCollection 2025.

Reference Type DERIVED
PMID: 40041104 (View on PubMed)

Other Identifiers

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RC 10-3-2023

Identifier Type: -

Identifier Source: org_study_id

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