Effects of Intraoperative Dexamethasone and Ondansetron on Postoperative Nausea and Vomiting in Microvascular Decompression Surgery

Khon Kaen University

Status: Completed

Conditions: Postoperative Nausea and Vomiting; Microvascular Decompression Surgery

Treatments: Drug: Dexamethasone; Drug: Ondansetron; Drug: 0.9% Sodium Chloride Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03685032

HE571218

Details and patient eligibility

About

Postoperative nausea and vomiting (PONV) is a common problem and may lead to catastrophic complications, especially in neurosurgical cases. The aim of this study was to evaluate the effects of dexamethasone and ondansetron for preventing PONV in patients who underwent microvascular decompression surgery (MVD).

Full description

A prospective, double-blinded randomized control trial was conducted with 54 patients who underwent MVD. Patients were allocated into two groups. The study group (Gr. D) received intraoperative dexamethasone 4 mg iv and ondansetron 4 mg iv, whereas the control group (Gr. N) received placebo (0.9% normal saline 1 ml iv and 0.9% normal saline 2 ml iv). The incidence and severity of PONV were observed at 1, 2, 4 and 24 hr post-surgery.

Enrollment: 54 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who were scheduled for MVD of trigeminal nerve root
• Patients who had a physical status classification of I to III according to the American Society of Anesthesiologists, and those who had a body mass index of 18 to 35 kg/m2

Exclusion criteria

• Patients on long-term administration of dexamethasone or ondansetron, those with a history of allergic reactions to dexamethasone or ondansetron, those who had undergone antiemetic therapy within 24 hr before surgery, those with underlying liver or renal failure, those who were pregnant, or those who had undergone emergency surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 2 patient groups, including a placebo group

The study group (Gr. D)

Experimental group

Description:

After patients received general anesthesia, a sequentially numbered opaque sealed envelope was opened. Gr. D was administered 4 mg of dexamethasone in 1 ml iv. At the end of the operation when suturing the dura mater, Gr. D received ondansetron 4 mg in 2 ml iv.

Treatment:

Drug: Ondansetron

Drug: Dexamethasone

the control group (Gr. N)

Placebo Comparator group

Description:

After patients received general anesthesia, a sequentially numbered opaque sealed envelope was opened. Gr. N received normal saline 1 ml iv. At the end of the operation when suturing the dura mater, Gr. N received normal saline 2 ml iv.

Treatment:

Drug: 0.9% Sodium Chloride Injection