The Comparison of Remimazolam With Propofol in Core Body Temperature
- Registration Number
- NCT05215834
- Lead Sponsor
- Wonkwang University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 90
- ASA physical classification I-III,
- Patients who undergoing Robotic-assisted or laparoscopic (LRP) radical prostatectomy.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RR group Remifentanil Remimazolam and Remifentanil group PR group Remifentanil Propofol and Remifentanil group
- Primary Outcome Measures
Name Time Method 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
Name Time Method Mean arterial pressure (mmHg) From after induction to until the end of surgery Mean arterial pressure
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
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
Trial Locations
- Locations (1)
Wonkwag UH
🇰🇷Iksan, Korea, Republic of