Respiratory Depression of Remimazolam vs. Propofol for Monitored Anesthesia Care

Not Applicable

Completed

• Conditions: Propofol; Hysteroscopic Surgery; Remimazolam; Respiratory Insufficiency; Hemodynamics Instability
• Interventions: Drug: Propofol; Drug: Remimazolam

• Registration Number: NCT07076628
• Lead Sponsor: DongGuk University

Brief Summary

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

Detailed Description

* 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.

Study Timeline

• Study First Submitted: 2022-02-02
• Study Start: 2023-08-24
• Primary Completion: 2025-05-30
• Study Completion: 2025-05-30
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-11
• Last Update Submitted: 2025-07-11
• Study First Posted: 2025-07-22
• Last Update Posted: 2025-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol group	Propofol	Propofol infusion with remifentanil for hysteroscopic surgery
Remimazolam group	Remimazolam	Remimazolam infusion with remifentanil for hysteroscopic surgery

Primary Outcome Measures

Name	Time	Method
Respiratory insufficiency before surgery	From the beginning of drug infusion until the moment of starting surgery (assessed up to 30 minutes)	Respiratory rate \< 9/min, Apnea \> 29 s, ETCO2 \> 54 mmHg, SpO2 \< 96%
Respiratory insufficiency during surgery	From the beginning of the surgery until the end of the drug infusion (assessed up to 60 minutes)	Respiratory rate \< 9/min, Apnea \> 29 s, ETCO2 \> 54 mmHg, SpO2 \< 96%

Secondary Outcome Measures

Name	Time	Method
Pain on injection	Just after the beginning of drug infusion	Patients will answer just after drug infusion begins (Yes or No)
Hypertension	Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes	\> 140 mmHg during Monitored Anesthetic Care (MAC)
Hypotension	Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes	\< 90 mmHg during the Monitored Anesthetic Care
Bradycardia	Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes	Heart rate \< 50/min during the Monitored Anesthetic Care
Tachycardia	Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes	Heart rate \> 100/min during the Monitored Anesthetic Care
Maximum ETCO2	Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes	ETCO2 will be measured every single respiration in the nasal cavity
Patient satisfaction with Monitored Anesthetic Care	Just before leaving the recovery room	4-point rating scale on the Satisfaction with MAC; (4: Fully satisfied, 3: Partially satisfied, 2: Partially unsatisfied,; 1: Totally unsatisfied)
Postoperative Nausea/Vomiting (PONV)	During staying at the recovery room (up to 60 minutes)	Patients are asked to answer yes/no on PONV, just before leaving the recovery room.

Trial Locations

Locations (1)

Dept. of anesthesiology and pain medicine, Dongguk University Ilsan Hospital; 🇰🇷 Goyang, Gyeonggido, Korea, Republic of