Respiratory Depression of Remimazolam vs. Propofol for Monitored Anesthesia Care

DongGuk University76 enrolled

Overview

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

* 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Propofol Remimazolam Hysteroscopic Surgery Respiratory Insufficiency Hemodynamics Instability

Interventions

PropofolDRUG

Propofol infusion with remifentanil

RemimazolamDRUG

Remimazolam infusion with remifentanil

Eligibility

Sex: FEMALEMin age: 19 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Dept. of anesthesiology and pain medicine, Dongguk University Ilsan Hospital

Goyang, Gyeonggido, South Korea

Outcomes

Primary Outcomes

Respiratory insufficiency before surgery

Respiratory rate \< 9/min, Apnea \> 29 s, ETCO2 \> 54 mmHg, SpO2 \< 96%

Time frame: From the beginning of drug infusion until the moment of starting surgery (assessed up to 30 minutes)

Respiratory insufficiency during surgery

Respiratory rate \< 9/min, Apnea \> 29 s, ETCO2 \> 54 mmHg, SpO2 \< 96%

Time frame: From the beginning of the surgery until the end of the drug infusion (assessed up to 60 minutes)

Secondary Outcomes

Pain on injection

Patients will answer just after drug infusion begins (Yes or No)

Time frame: Just after the beginning of drug infusion

Hypertension

\> 140 mmHg during Monitored Anesthetic Care (MAC)

Time frame: Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes

Hypotension

\< 90 mmHg during the Monitored Anesthetic Care

Time frame: Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes

Bradycardia

Heart rate \< 50/min during the Monitored Anesthetic Care

Time frame: Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes

Tachycardia

Heart rate \> 100/min during the Monitored Anesthetic Care

Time frame: Through the Monitored Anesthetic Care (From the beginning of drug infusion until the end of the drug infusion) up to 60 minutes

Data from ClinicalTrials.gov

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