The Comparison of Remimazolam With Propofol in Core Body Temperature

NCT ID: NCT05215834

Last Updated: 2022-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-11-30

Brief Summary

1. Core body temperature is normally tightly regulated to within a few tenths of a degree. The major thermoregulatory defences in humans are sweating, arteriovenous shunt vasoconstriction, and shivering.

2. Inadvertent hypothermia often complicates prolonged surgery. In patients becoming sufficiently hypothermic, reemergence of thermoregulatory vasoconstriction usually prevents further core hypothermia.

3. The extent to which anesthetics reduce the vasoconstriction threshold depends on the type of drug and its concentration.

Detailed Description

1. When propofol induces anesthesia, blood pressure decreases due to vasodilation, which is due to direct action on vascular smooth muscle and vasodilation due to blockage of the sympathetic nervous system. This results in a redistribution of body temperature, resulting in hypothermia.

2. The effects of remimazolam on the central nervous system, respiratory and cardiovascular system have been studied. Remimazolam, a new type of benzodiazepine drug acts on the GABA-A receptor and has the advantages of rapid induction, rapid recovery, stable hemodynamics, and mild respiratory inhibition. At present, there is little literature on its practice in intraoperative thermoregulation under general anesthesia.

3. Investigators hypothesized that the type of anesthetic agents might affect thermoregulatory mechanisms such as the redistribution of body heat, cutaneous heat loss or inhibition of thermoregulatory vasoconstriction. Therefore, Investigators investigated to compare remimazolam with propofol in core body temperature, vasoconstriction threshold and times to onset of vasoconstriction(min)in patients given laparoscopic assisted vaginal hysterectormy.

Conditions

Hypothermia; Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

PR group

Propofol and Remifentanil group

Group Type: ACTIVE_COMPARATOR

Remifentanil

Intervention Type: DRUG

1. Remimazolm and Remifentanil (RR group): anesthesia was induced with remimazolam 6 mg/kg/h by continuous intravenous (IV) infusion and with the effect-site concentration of remifentanil 4 ng/ml and until the loss of consciousness (LoC), followed by remimazolam 1-2 mg/kg/h and remifentanil 3 ng/ml until the end of surgery.

2. Propofol and Remifentanil (PR group), anesthesia was induced with the effect-site concentration of propofol of 6.0 μg/ml and remifentanil 4 ng/ml, and until the loss of consciousness (LoC), followed by the effect-site concentration of propofol of 2-4 μg/ml and remifentanil 3 ng/ml until the end of surgery.

RR group

Remimazolam and Remifentanil group

Group Type: EXPERIMENTAL

Remifentanil

Intervention Type: DRUG

1. Remimazolm and Remifentanil (RR group): anesthesia was induced with remimazolam 6 mg/kg/h by continuous intravenous (IV) infusion and with the effect-site concentration of remifentanil 4 ng/ml and until the loss of consciousness (LoC), followed by remimazolam 1-2 mg/kg/h and remifentanil 3 ng/ml until the end of surgery.

2. Propofol and Remifentanil (PR group), anesthesia was induced with the effect-site concentration of propofol of 6.0 μg/ml and remifentanil 4 ng/ml, and until the loss of consciousness (LoC), followed by the effect-site concentration of propofol of 2-4 μg/ml and remifentanil 3 ng/ml until the end of surgery.

Interventions

Remifentanil

1. Remimazolm and Remifentanil (RR group): anesthesia was induced with remimazolam 6 mg/kg/h by continuous intravenous (IV) infusion and with the effect-site concentration of remifentanil 4 ng/ml and until the loss of consciousness (LoC), followed by remimazolam 1-2 mg/kg/h and remifentanil 3 ng/ml until the end of surgery.

2. Propofol and Remifentanil (PR group), anesthesia was induced with the effect-site concentration of propofol of 6.0 μg/ml and remifentanil 4 ng/ml, and until the loss of consciousness (LoC), followed by the effect-site concentration of propofol of 2-4 μg/ml and remifentanil 3 ng/ml until the end of surgery.

Intervention Type: DRUG

Other Intervention Names

propofol or remimazolam

Eligibility Criteria

Inclusion Criteria

1. ASA physical classification I-III,

2. Patients who undergoing Robotic-assisted or laparoscopic (LRP) radical prostatectomy.

Exclusion Criteria

1. Patients who have Medications or any implanted device that could affect cardiovascular function

2. Patients who have a history with heat imbalance, thyroid diseases, dystautonomia, Raynaud's syndrome, uncontrolled diabetes mellitus, or hypertension.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Wonkwang University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cheol Lee,MD,PhD,

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cheol Lee, M.D.,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of anesthesiology and pain medicine, Wonkwang University Hospital

Locations

Wonkwag UH

Iksan, , South Korea

Countries

South Korea

Other Identifiers

WonkwangUH9

Identifier Type: -

Identifier Source: org_study_id