The Comparison of Remimazolam With Propofol in Core Body Temperature

Sponsor

Wonkwang University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05215834

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.
Inadvertent hypothermia often complicates prolonged surgery. In patients becoming sufficiently hypothermic, reemergence of thermoregulatory vasoconstriction usually prevents further core hypothermia.
The extent to which anesthetics reduce the vasoconstriction threshold depends on the type of drug and its concentration.

Condition or Disease	Intervention/Treatment	Phase
Hypothermia; Anesthesia	Drug: Remifentanil	Phase 4

Detailed Description

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.
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.
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective randomized and cohort studyProspective randomized and cohort study

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

The Comparison of Remimazolam With Propofol in Core Body Temperature in Patients Undergoing Robotic-assisted (RARP) and Laparoscopic (LRP) Radical Prostatectomy

Actual Study Start Date :

Mar 1, 2021

Actual Primary Completion Date :

Jun 30, 2021

Actual Study Completion Date :

Nov 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PR group Propofol and Remifentanil group	Drug: Remifentanil 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. 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. Other Names: propofol or remimazolam
Experimental: RR group Remimazolam and Remifentanil group	Drug: Remifentanil 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. 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. Other Names: propofol or remimazolam

Arm

Intervention/Treatment

Active Comparator: PR group

Propofol and Remifentanil group

Drug: Remifentanil

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. 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.

Other Names:

propofol or remimazolam

Experimental: RR group

Remimazolam and Remifentanil group

Drug: Remifentanil

Other Names:

propofol or remimazolam

Outcome Measures

Primary Outcome Measures

core body temperature change (°C) [at 60 minutes after induction of general anesthesia]
After the induction of general anesthesia, a nasopharyngeal temperature probe was inserted through the nasal cavity, and a 9.5- to 10.0-cm depth was set for optimal placement. The nasopharyngeal temperature was recorded every 10 min until the end of surgery

Secondary Outcome Measures

times to onset of vasoconstriction (minute) [From after induction to until the end of surgery]
time to arrive the skin temperature gradient (between forearm and index finger tip) equaled 0 °C.
intraoperative hypothermia [From after induction to until the end of surgery]
core body temperature of <36 °C in patients undergoing anesthesia and surgery
Mean arterial pressure (mmHg) [From after induction to until the end of surgery]
Mean arterial pressure
Heart rate (beats/min) [From after induction to until the end of surgery]
Heart rate
vasoconstriction threshold (°C) [From after induction to until the end of surgery]
the tympanic membrane temperature at which the skin temperature gradient (between forearm and index finger tip) equaled 0 °C

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 75 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

ASA physical classification I-III,
Patients who undergoing Robotic-assisted or laparoscopic (LRP) radical prostatectomy.

Exclusion Criteria:

Patients who have Medications or any implanted device that could affect cardiovascular function
Patients who have a history with heat imbalance, thyroid diseases, dystautonomia, Raynaud's syndrome, uncontrolled diabetes mellitus, or hypertension.