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

Al-Azhar University

Status and phase: Completed; Phase 3

Conditions: Laparoscopic Cholecystectomy; Postoperative Nausea and Vomiting

Treatments: Drug: Dexamethasone; Drug: Dexmedetomidine; Drug: normal Saline; Drug: Combination of dexamethasone + dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT05988671

RC 10-3-2023

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 4 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

received 20 ml normal saline

Treatment:

Drug: normal Saline

dexamethasone group

Active Comparator group

Description:

received 8mg dexamethasone

Treatment:

Drug: Dexamethasone

dexmedetomidine group

Active Comparator group

Description:

received dexmedetomidine 1mic/kg

Treatment:

Drug: Dexmedetomidine

combined group

Active Comparator group

Description:

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

Treatment:

Drug: Combination of dexamethasone + dexmedetomidine