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

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

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-07

Study Completion Date

2016-02-16

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Microvascular Decompression Surgery Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blinded randomized control trial was conducted. The investigators allocated patients into two arm.

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)

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The study drugs based on a sequentially numbered list were prepared in the same way. These drugs had similar characteristics, including clear color and no observable particles, and were loaded into syringes labeled for each group. The attending anesthesiologists, anesthetic nurses, and ward nurses, as well as the patients were blinded to the computer-generated randomization lists.

Study Groups

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The study group (Gr. D)

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.

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

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

Ondansetron

Intervention Type DRUG

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

the control group (Gr. N)

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.

Group Type PLACEBO_COMPARATOR

0.9% Sodium Chloride Injection

Intervention Type DRUG

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.

Interventions

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Dexamethasone

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

Intervention Type DRUG

Ondansetron

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

Intervention Type DRUG

0.9% Sodium Chloride Injection

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.

Intervention Type DRUG

Other Intervention Names

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Lodexa Onsia

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No