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

Khon Kaen University54 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Microvascular Decompression Surgery Postoperative Nausea and Vomiting

Interventions

DexamethasoneDRUG

The 4 mg of dexamethasone in 1 ml intravenous was administrated after patient received general anesthesia

OndansetronDRUG

The 4 mg of ondansetron in 2 ml intravenous was administrated at the end of the operation.

0.9% Sodium Chloride InjectionDRUG

The 0.9% sodium chloride in 1 ml intravenous was administrated after patient received general anesthesia. At the end of operation, the 0.9% sodium chloride in 2 ml intravenous was administrated.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Khon Kaen University

Khon Kaen, Thailand

Outcomes

Primary Outcomes

Change in incidence of postoperative nausea and vomiting

Postoperative nausea and vomiting events was recorded by blinded anesthesiologists, blinded anesthetic nurses, and blinded ward nurses.

Time frame: The incidence was recorded at 1 hour as a baseline and changing incidences from baseline were recorded at 2 hours, 4 hours, and 24 hours.

Secondary Outcomes

Pain score

The intensity of postoperative pain was measured with a numeric rating scale (NRS: 0=no pain, 10=severe pain)

Time frame: The intensity of pain was recorded at 1 hour and 2 hours in the postoperative period in the recovery room and at 4 hours and 24 hours in the ward.

opioid analgesics consumed

opioid analgesics consumed was recorded by blinded anesthesiologists, blinded anesthetic nurses, and blinded ward nurses.

Time frame: The opioid analgesics used was recorded at 1 hour and 2 hours in the postoperative period in the recovery room and at 4 hours and 24 hours in the ward.

severity of postoperative nausea and vomiting

Severity of postoperative nausea and vomiting was recorded by blinded anesthesiologists, blinded anesthetic nurses, and blinded ward nurses. Level of severity of PONV (0=no symptoms; 1=mild: few symptoms and not requiring treatment; 2=moderate: presented symptoms and needed ondansetron 8 mg iv; 3=severe: persisted symptoms after received ondansetron 8 mg iv and needed re-administration of ondansetron 8 mg iv)

Time frame: The severity of postoperative nausea and vomiting was recorded at 1 hour and 2 hours in the postoperative period in the recovery room and at 4 hours and 24 hours in the ward.

Antiemetics used

Antiemetics used was recorded by blinded anesthesiologists, blinded anesthetic nurses, and blinded ward nurses.

Time frame: The antiemetic used was recorded at 1 hour and 2 hours in the postoperative period in the recovery room and at 4 hours and 24 hours in the ward.

Data from ClinicalTrials.gov

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