Respiratory Depression of Remimazolam vs. Propofol for Monitored Anesthesia Care

DongGuk University

Status and phase: Completed; Phase 4

Conditions: Remimazolam; Propofol; Respiratory Insufficiency; Hemodynamics Instability; Hysteroscopic Surgery

Treatments: Drug: Propofol; Drug: Remimazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT07076628

J In 2021-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 76 patients

Sex: Female

Ages: 19 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

76 participants in 2 patient groups

Propofol group

Active Comparator group

Description:

Propofol infusion with remifentanil for hysteroscopic surgery

Treatment:

Drug: Propofol

Remimazolam group

Active Comparator group

Description:

Remimazolam infusion with remifentanil for hysteroscopic surgery

Treatment:

Drug: Remimazolam