Respiratory Depression of Remimazolam vs. Propofol for Monitored Anesthesia Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-24

Study Completion Date

2025-05-30

Brief Summary

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The comparison of incidence of respiratory depression between remimazolam and propofol under monitored anesthesia care for hysteroscopic surgery

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Detailed Description

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* Non-invasive blood pressure, electrocardiogram, and oxygen saturation sensors are attached.

* Wear an oxygen mask (5L per minute), and place the sampling line for end-tidal carbon dioxide partial pressure measurement inside the nose.

* Check the randomization table to determine the drug to be administered, and prepare propofol or remimazolam accordingly.

* Record the baseline values (0 min).

* Start administration of Remifentanil.

⑥ Administer anesthesia to adjust the maintenance dose to reach a sedation level of 2 or less on the MOAA/S scale.

⑦ Adjust the remifentanil dose according to the patient's response

⑧ When the target sedation level is reached, the surgical preparation process and surgery begin, and the study variables are observed and recorded at 5-minute intervals.

⑨ Stop drug administration upon end of surgery.

⑩ After confirming proper recovery of consciousness and spontaneous breathing, leave the recovery room.

⑪ Before leaving the recovery room, check the complete recovery and investigate the patient's satisfaction with anesthesia.

Conditions

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Propofol Remimazolam Hysteroscopic Surgery Respiratory Insufficiency Hemodynamics Instability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be enrolled to one of the two drug groups with randomization.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Care giver will notice which drug will be given to the patients because of the color (White vs clear) and infusion doses of the drugs.

Study Groups

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Propofol group

Propofol infusion with remifentanil for hysteroscopic surgery

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Propofol infusion with remifentanil

Remimazolam group

Remimazolam infusion with remifentanil for hysteroscopic surgery

Group Type ACTIVE_COMPARATOR

Remimazolam

Intervention Type DRUG

Remimazolam infusion with remifentanil

Interventions

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Propofol

Propofol infusion with remifentanil

Intervention Type DRUG

Remimazolam

Remimazolam infusion with remifentanil

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ASA PS 1-2
* Elective hysteroscopic surgery under monitored anesthesia care
* No drug abuse history

Exclusion Criteria

* BMI \> 30 kg/m2
* Hepatic or renal insufficiency
* Alcohol abuse
* Respiratory, hemodynamic compromise, or diseases
* History of general/regional anesthesia during the last month
* A patient who is taking sedatives or analgesics
* Under the investigator's judgment

Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No