Back to resultsEffects of Intraoperative Dexamethasone and Ondansetron on Postoperative Nausea and Vomiting in Microvascular Decompression Surgery
Primary Purpose
Microvascular Decompression Surgery, Postoperative Nausea and Vomiting
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Dexamethasone
Ondansetron
0.9% Sodium Chloride Injection
Sponsored by
About this trial
This is an interventional treatment trial for Microvascular Decompression Surgery
Eligibility Criteria
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.
Sites / Locations
- Khon Kaen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
The study group (Gr. D)
the control group (Gr. N)
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pain score
The intensity of postoperative pain was measured with a numeric rating scale (NRS: 0=no pain, 10=severe pain)
opioid analgesics consumed
opioid analgesics consumed was recorded by blinded anesthesiologists, blinded anesthetic nurses, and blinded ward nurses.
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)
Antiemetics used
Antiemetics used was recorded by blinded anesthesiologists, blinded anesthetic nurses, and blinded ward nurses.
Full Information
NCT ID
NCT03685032
First Posted
September 23, 2018
Last Updated
September 24, 2018
Sponsor
Khon Kaen University
1. Study Identification
Unique Protocol Identification Number
NCT03685032
Brief Title
Effects of Intraoperative Dexamethasone and Ondansetron on Postoperative Nausea and Vomiting in Microvascular Decompression Surgery
Official Title
Effects of Intraoperative Dexamethasone and Ondansetron on Postoperative Nausea and Vomiting in Microvascular Decompression Surgery: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
August 7, 2014 (Actual)
Primary Completion Date
February 16, 2016 (Actual)
Study Completion Date
February 16, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microvascular Decompression Surgery, Postoperative Nausea and Vomiting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The study group (Gr. D)
Arm Type
Experimental
Arm 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.
Arm Title
the control group (Gr. N)
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Lodexa
Intervention Description
The 4 mg of dexamethasone in 1 ml intravenous was administrated after patient received general anesthesia
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Other Intervention Name(s)
Onsia
Intervention Description
The 4 mg of ondansetron in 2 ml intravenous was administrated at the end of the operation.
Intervention Type
Drug
Intervention Name(s)
0.9% Sodium Chloride Injection
Intervention Description
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 Outcome Measure Information:
Title
Change in incidence of postoperative nausea and vomiting
Description
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 Outcome Measure Information:
Title
Pain score
Description
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.
Title
opioid analgesics consumed
Description
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.
Title
severity of postoperative nausea and vomiting
Description
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.
Title
Antiemetics used
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pornthep Kasemsiri, MD
Organizational Affiliation
Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
26257852
Citation
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.
Results Reference
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Effects of Intraoperative Dexamethasone and Ondansetron on Postoperative Nausea and Vomiting in Microvascular Decompression Surgery
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