Clinical trial NCT05215834: The Comparison of Remimazolam With Propofol in Core Body Temperature
Official title: The Comparison of Remimazolam With Propofol in Core Body Temperature in Patients Undergoing Robotic-assisted (RARP) and Laparoscopic (LRP) Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypothermia; Anesthesia
Keywords: hypothermia
vasoconstriction threshold
propofol
remimazolam
Lead sponsor: Wonkwang University Hospital
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 90
Sex: MALE
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized and cohort study
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: core body temperature change (°C)
timeFrame: at 60 minutes after induction of general anesthesia
Secondary outcomes:
measure: times to onset of vasoconstriction (minute)
timeFrame: From after induction to until the end of surgery
measure: intraoperative hypothermia
timeFrame: From after induction to until the end of surgery
measure: Mean arterial pressure (mmHg)
timeFrame: From after induction to until the end of surgery
measure: Heart rate (beats/min)
timeFrame: From after induction to until the end of surgery
measure: vasoconstriction threshold (°C)
timeFrame: From after induction to until the end of surgery
Other outcomes:
Locations:
city: Iksan
country: Korea, Republic of
facility: Wonkwag UH
Study officials:
affiliation: Department of anesthesiology and pain medicine, Wonkwang University Hospital
name: Cheol Lee, M.D.,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: