The Comparison of Remimazolam With Propofol in Core Body Temperature

Wonkwang University Hospital

Status and phase: Completed; Phase 4

Conditions: Hypothermia; Anesthesia

Treatments: Drug: Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT05215834

WonkwangUH9

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: Male

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

PR group

Active Comparator group

Description:

Propofol and Remifentanil group

Treatment:

Drug: Remifentanil

RR group

Experimental group

Description:

Remimazolam and Remifentanil group

Treatment:

Drug: Remifentanil