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Comparison of Remimazolam and Midazolam for Preventing Intraoperative Nausea and Vomiting During Cesarean Section Under Spinal Anesthesia

Primary Purpose

Pregnancy, Cesarean Section, Spinal Anesthesia

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Remimazolam besylate
Midazolam
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pregnancy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Patients (age ≥ 20yrs and ASA Class II or III) who are scheduled for elective Cesarean section Exclusion Criteria: Emergency surgery Patients who are diagnosed preeclampsia or eclampsia, BMI ≥ 40kg/m2, IUP < 36 weeks Patients with contraindications to spinal anesthesia Patients who do not want sedation during the procedure

Sites / Locations

  • Yonsei University Health System, Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Remimazolam

Midazolam

Arm Description

Patient group who receives remimazolam for sedation after delivery

Patient group who receives midazolam for sedation after delivery

Outcomes

Primary Outcome Measures

intraoperative nausea and vomiting during sedative period
Incidence of intraoperative nausea, retching, and vomiting will be evaluated 5, 10, 15, 20, 25, 30, and 60 minutes after sedative administration, and at the end of surgery.
intraoperative nausea and vomiting during sedative period
Incidence of intraoperative nausea, retching, and vomiting will be evaluated 5, 10, 15, 20, 25, 30, and 60 minutes after sedative administration, and at the end of surgery.
intraoperative nausea and vomiting during sedative period
Incidence of intraoperative nausea, retching, and vomiting will be evaluated 5, 10, 15, 20, 25, 30, and 60 minutes after sedative administration, and at the end of surgery.
intraoperative nausea and vomiting during sedative period
Incidence of intraoperative nausea, retching, and vomiting will be evaluated 5, 10, 15, 20, 25, 30, and 60 minutes after sedative administration, and at the end of surgery.
intraoperative nausea and vomiting during sedative period
Incidence of intraoperative nausea, retching, and vomiting will be evaluated 5, 10, 15, 20, 25, 30, and 60 minutes after sedative administration, and at the end of surgery.
intraoperative nausea and vomiting during sedative period
Incidence of intraoperative nausea, retching, and vomiting will be evaluated 5, 10, 15, 20, 25, 30, and 60 minutes after sedative administration, and at the end of surgery.
intraoperative nausea and vomiting during sedative period
Incidence of intraoperative nausea, retching, and vomiting will be evaluated 5, 10, 15, 20, 25, 30, and 60 minutes after sedative administration, and at the end of surgery.
intraoperative nausea and vomiting during sedative period
Incidence of intraoperative nausea, retching, and vomiting will be evaluated 5, 10, 15, 20, 25, 30, and 60 minutes after sedative administration, and at the end of surgery.

Secondary Outcome Measures

Full Information

First Posted
February 1, 2023
Last Updated
June 29, 2023
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT05736341
Brief Title
Comparison of Remimazolam and Midazolam for Preventing Intraoperative Nausea and Vomiting During Cesarean Section Under Spinal Anesthesia
Official Title
Comparison of Remimazolam and Midazolam for Preventing Intraoperative Nausea and Vomiting During Cesarean Section Under Spinal Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Spinal anesthesia is widely accepted as the anesthetic method of choice for Cesarean section. However, high-level blockage or hypotension induced by this technique may induce intraoperative nausea and vomiting (IONV), which is associated with patient discomfort and protrusion of abdominal viscera which may adversely affect patient safety. To prevent IONV, midazolam is frequently administered after delivery, but risk of hypotension and prolonged sedation due to its active metabolite also increases. On the other hand, remimazolam is known to have relatively shorter half-life and less likely induce hypotension when compared to midazolam, yet its effect on IONV has not been thoroughly evaluated. Hence, this study aimed to compare the effects of remimazolam and midazolam in preventing IONV in patients scheduled for elective Cesarean section.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Cesarean Section, Spinal Anesthesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remimazolam
Arm Type
Experimental
Arm Description
Patient group who receives remimazolam for sedation after delivery
Arm Title
Midazolam
Arm Type
Active Comparator
Arm Description
Patient group who receives midazolam for sedation after delivery
Intervention Type
Drug
Intervention Name(s)
Remimazolam besylate
Intervention Description
After delivery, patients in this group receives 5mg of remimazolam to induce sedation during the remaining procedures of Cesarean section.
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
After delivery, patients in this group receives 2mg of midazolam to induce sedation during the remaining procedures of Cesarean section.
Primary Outcome Measure Information:
Title
intraoperative nausea and vomiting during sedative period
Description
Incidence of intraoperative nausea, retching, and vomiting will be evaluated 5, 10, 15, 20, 25, 30, and 60 minutes after sedative administration, and at the end of surgery.
Time Frame
at 5 minutes after sedative administration
Title
intraoperative nausea and vomiting during sedative period
Description
Incidence of intraoperative nausea, retching, and vomiting will be evaluated 5, 10, 15, 20, 25, 30, and 60 minutes after sedative administration, and at the end of surgery.
Time Frame
at 10 minutes after sedative administration
Title
intraoperative nausea and vomiting during sedative period
Description
Incidence of intraoperative nausea, retching, and vomiting will be evaluated 5, 10, 15, 20, 25, 30, and 60 minutes after sedative administration, and at the end of surgery.
Time Frame
at 15 minutes after sedative administration
Title
intraoperative nausea and vomiting during sedative period
Description
Incidence of intraoperative nausea, retching, and vomiting will be evaluated 5, 10, 15, 20, 25, 30, and 60 minutes after sedative administration, and at the end of surgery.
Time Frame
at 20 minutes after sedative administration
Title
intraoperative nausea and vomiting during sedative period
Description
Incidence of intraoperative nausea, retching, and vomiting will be evaluated 5, 10, 15, 20, 25, 30, and 60 minutes after sedative administration, and at the end of surgery.
Time Frame
at 25 minutes after sedative administration
Title
intraoperative nausea and vomiting during sedative period
Description
Incidence of intraoperative nausea, retching, and vomiting will be evaluated 5, 10, 15, 20, 25, 30, and 60 minutes after sedative administration, and at the end of surgery.
Time Frame
at 30 minutes after sedative administration
Title
intraoperative nausea and vomiting during sedative period
Description
Incidence of intraoperative nausea, retching, and vomiting will be evaluated 5, 10, 15, 20, 25, 30, and 60 minutes after sedative administration, and at the end of surgery.
Time Frame
at 60 minutes after sedative administration
Title
intraoperative nausea and vomiting during sedative period
Description
Incidence of intraoperative nausea, retching, and vomiting will be evaluated 5, 10, 15, 20, 25, 30, and 60 minutes after sedative administration, and at the end of surgery.
Time Frame
at the end of surgery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
As this study evaluates intraoperative nausea and vomiting during Cesarean section, only female participants are eligible to this study.
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients (age ≥ 20yrs and ASA Class II or III) who are scheduled for elective Cesarean section Exclusion Criteria: Emergency surgery Patients who are diagnosed preeclampsia or eclampsia, BMI ≥ 40kg/m2, IUP < 36 weeks Patients with contraindications to spinal anesthesia Patients who do not want sedation during the procedure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seung Hyun Kim
Phone
82-10-3292-2351
Email
anesshkim@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung Hyun Kim
Organizational Affiliation
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung Hyun Kim
Phone
82-10-3292-2351
Email
anesshkim@yuhs.ac

12. IPD Sharing Statement

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Comparison of Remimazolam and Midazolam for Preventing Intraoperative Nausea and Vomiting During Cesarean Section Under Spinal Anesthesia

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