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NCT Number: NCT03685032

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

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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Key information

Conditions

Microvascular Decompression Surgery Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Khon Kaen University

Khon Kaen, 40002, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone

Drug

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

Other names: Lodexa

ondansetron

Drug

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

Other names: Onsia

0.9% sodium chloride injection

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.

Primary outcomes

  1. Change in incidence of postoperative nausea and vomiting

    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.

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

Secondary outcomes

  1. Pain score

    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.

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

  2. opioid analgesics consumed

    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.

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

  3. severity of postoperative nausea and vomiting

    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.

    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)

  4. Antiemetics used

    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.

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

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study title

Effects of Intraoperative Dexamethasone and Ondansetron on Postoperative Nausea and Vomiting in Microvascular Decompression Surgery: A Randomized Controlled Study

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 26, 2018
Registry last updated
Sep 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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