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

NCT03685032 | Completed

• 1 other identifier: HE571218
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Microvascular Decompression Surgery; Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• 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.

  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 (4)

• Pain score

  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

  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

  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

  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.

Study Arms (2)

The study group (Gr. D)

EXPERIMENTAL

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.

Drug: Dexamethasone; Drug: Ondansetron

the control group (Gr. N)

PLACEBO COMPARATOR

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.

Drug: 0.9% Sodium Chloride Injection

Interventions

Dexamethasone DRUG

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

Also known as: Lodexa

The study group (Gr. D)

Ondansetron DRUG

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

Also known as: Onsia

The study group (Gr. D)

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.

the control group (Gr. N)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Khon Kaen University

Khon Kaen, 40002, Thailand

Location

Related Publications (1)

• Ha SH, Kim H, Ju HM, Nam DJ, Min KT. Comparison of the antiemetic effect of ramosetron with ondansetron in patients undergoing microvascular decompression with retromastoid craniotomy: a preliminary report. Korean J Anesthesiol. 2015 Aug;68(4):386-91. doi: 10.4097/kjae.2015.68.4.386. Epub 2015 Jul 28.

  PMID: 26257852 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Dexamethasone; Ondansetron; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Pornthep Kasemsiri, MD

  Khon Kaen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: 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)

Study Record Dates

• First Submitted: September 23, 2018
• First Posted: September 26, 2018
• Study Start: August 7, 2014
• Primary Completion: February 16, 2016
• Study Completion: February 16, 2016
• Last Updated: September 26, 2018

Record last verified: 2018-09

Locations

TH (1)