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Effect of Intramuscular Midazolam Premedication on Overall Anesthesia Satisfaction in Female General Anesthesia Patients

Status Approved

First Submitted Date

2021/03/10
Registered Date

2021/03/16
Last Updated Date

2022/02/07

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0006002
Unique Protocol ID	CR320166
Public/Brief Title	Effect of Intramuscular Midazolam premedication on Anesthesia Satisfaction in Female Patients
Scientific Title	Effect of Intramuscular Midazolam Premedication on Overall Anesthesia Satisfaction in Female General Anesthesia Patients
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	CR320166
Approval Date	2021-02-17
Institutional Review Board Name	Yonsei University Wonju Severance Christian Hospital Institutional Review Board
Institutional Review Board Address	20, Ilsan-ro, Wonju-si, Gangwon-do
Institutional Review Board Telephone	033-741-1703
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Seung Woo Song
Title	M.D.
Telephone	+82-33-741-1536
Affiliation	Yonsei University
Address	Department of Anesthesiology and Pain Medicine, Wonju Severance Christian Hospital, Ilsan-ro 20, Wonju-si, Gangwon-do, 26426, Rep. of KOREA
Contact Person for Public Queries
Name	Seung Woo Song
Title	M.D.
Telephone	+82-33-741-1536
Affiliation	Yonsei University
Address	Department of Anesthesiology and Pain Medicine, Wonju Severance Christian Hospital, Ilsan-ro 20, Wonju-si, Gangwon-do, 26426, Rep. of KOREA
Contact Person for Updating Information
Name	Seung Woo Song
Title	M.D.
Telephone	+82-33-741-1536
Affiliation	Yonsei University
Address	Department of Anesthesiology and Pain Medicine, Wonju Severance Christian Hospital, Ilsan-ro 20, Wonju-si, Gangwon-do, 26426, Rep. of KOREA

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2021-03-17 Actual
Target Number of Participant	140
Primary Completion Date	2021-08-18 , Actual
Study Completion Date	2021-08-18 , Actual
Name of Study	Yonsei University, Wonju Severance Christian Hospital
Recruitment Status	Completed
Date of First Enrollment	2021-03-17 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Yonsei University Wonju College of Medicine
Organization Type	University
Project ID	CR320166

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Yonsei University Wonju College of Medicine
Organization Type	University

7. Study Summary

Study Summary Information
Lay Summary	1) Background Midazolam is a benzodiazepine widely used for sedation and anesthesia. It is a drug that has advantages such as anterograde amnesia, less hemodynamic changes when administered with a sedative dose, and a short half-life. Many patients experience preoperative anxiety and the incidence rate is reported to be 60-80% depending on the study. In the case of patients with severe preoperative anxiety, satisfaction after surgery may be low. Therefore, midazolam is sometimes administered as a preoperative anxiolytic. Many previous studies have studied premedication of benzodiazepine by oral, intramuscular, or intravenous injection to alleviate anxiety before surgery. There is also an opinion that it is not recommended to routinely administer sedation drugs before surgery. However, in the study of this view, only oral lorazepam was used and the time of administration was the day before surgery. In contrast, there is a study that reported an increase in patient satisfaction with intravenous midazolam premedication immediately before endoscopy. The timing of administration can be important and there was also a study in which premedication was administered intravenously 30 minutes before the oocyte collection procedure, alleviating the anxiety of the intervention group. When designing this study, we considered which patient group could experience better patient satisfaction through midazolam premedication. Until now, it has been found that young people are more anxious than the elderly and females are more anxious than males. Therefore, we established the purpose of this study to confirm whether midazolam premedication through intramuscular injection can improve the overall satisfaction of anesthesia in young adult female patients (19-65 years old) receiving general anesthesia compared to placebo. 2) Hypothesis Midazolam 0.05mg/kg intramuscular injection administered ten minutes before leaving the ward improves the overall satisfaction of anesthesia, compared to placebo. 3) Research method - Double blind randomized controlled trial 4) Primary outcome Satisfaction score (NRS 0-4; 0=very unsatisfied, 1=unsatisfied, 2=neutral, 3=satisfied, 4=very satisfied)

Study Summary Information

Lay Summary

1) Background

Midazolam is a benzodiazepine widely used for sedation and anesthesia. It is a drug that has advantages such as anterograde amnesia, less hemodynamic changes when administered with a sedative dose, and a short half-life. Many patients experience preoperative anxiety and the incidence rate is reported to be 60-80&#37; depending on the study. In the case of patients with severe preoperative anxiety, satisfaction after surgery may be low. Therefore, midazolam is sometimes administered as a preoperative anxiolytic.

Many previous studies have studied premedication of benzodiazepine by oral, intramuscular, or intravenous injection to alleviate anxiety before surgery. There is also an opinion that it is not recommended to routinely administer sedation drugs before surgery. However, in the study of this view, only oral lorazepam was used and the time of administration was the day before surgery. In contrast, there is a study that reported an increase in patient satisfaction with intravenous midazolam premedication immediately before endoscopy. The timing of administration can be important and there was also a study in which premedication was administered intravenously 30 minutes before the oocyte collection procedure, alleviating the anxiety of the intervention group.

When designing this study, we considered which patient group could experience better patient satisfaction through midazolam premedication. Until now, it has been found that young people are more anxious than the elderly and females are more anxious than males. Therefore, we established the purpose of this study to confirm whether midazolam premedication through intramuscular injection can improve the overall satisfaction of anesthesia in young adult female patients (19-65 years old) receiving general anesthesia compared to placebo.

2) Hypothesis
Midazolam 0.05mg/kg intramuscular injection administered ten minutes before leaving the ward improves the overall satisfaction of anesthesia, compared to placebo.

3) Research method
- Double blind randomized controlled trial

4) Primary outcome
Satisfaction score (NRS 0-4; 0=very unsatisfied, 1=unsatisfied, 2=neutral, 3=satisfied, 4=very satisfied)

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Phase4
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Drug
Intervention Description	For the intervention group, 0.05mg/kg of midazolam is administered by intramuscular injection right after arriving the pre-operative holding area. For the control group, an equal amount of saline is administered by intramuscular injection as a placebo at the same time point.
Number of Arms	2
Arm 1	Arm Label Intervention group
	Target Number of Participant 70
	Arm Type Experimental
	Arm Description 0.05mg/kg of midazolam is administered by intramuscular injection right after arriving the pre-operative holding area.
Arm 2	Arm Label Control group
	Target Number of Participant 70
	Arm Type Placebo comparator
	Arm Description Normal saline 0.01mL/kg is administrated by intramuscular injection right after arriving the pre-operative holding area.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	Not Applicable-Anesthesia Female patients undergoing general anesthesia
Rare Disease	No
Inclusion Criteria	Gender Female
	Age 19Year~65Year
	Description > Patients undergoing general anesthesia for elective surgery > Female > 19 - 65 years old > Americlan Society of Anesthesiologist physical status classification (ASA PS classification) I, II
Exclusion Criteria	- Day surgeries or emergency surgeries - ASA PS classification ≥ III - Body mass index ≥ 30 - airway obstruction or dyspnea (e.g. formerly diagnosed obstructive sleep apnea, myasthenia gravis) - Hypersensitivity to benzodiazepines - current administration of benzodiazepines for other reasons - Pregnant or nursing women - Hepatic dysfunction of CTP class C - Acute narrow angle glaucoma - Inability to communicate because of cognitive impairment - Patients who cannot understand the consent form
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Overall satisfaction of anesthesia (NRS 0-4)
Timepoint	A day after surgery
Secondary Outcome(s) 1
Outcome	Safety profile(heart rate, blood pressure, incidence of hypoxia)
Timepoint	arrival at the preoperative holding area, arrival at the operating theater, 20 minutes after recovery
Secondary Outcome(s) 2
Outcome	duration of recovery
Timepoint	immediate post-operative period
Secondary Outcome(s) 3
Outcome	postoperastive pain (NRS-10)
Timepoint	After twenty minutes of recovery, POD1
Secondary Outcome(s) 4
Outcome	Administration of rescue anti-emetics
Timepoint	in the PACU

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Yes
Time of Sharing	2022. 3
Way of Sharing	Other (Available upon reasonable request.)

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