The Comparison of Remimazolam With Propofol in Core Body Temperature
Condition: Hypothermia; Anesthesia
MeSH terms: Hypothermia
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Remifentanil
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): propofol or remimazolam
Intervention MeSH terms: Remifentanil; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective randomized and cohort study
Masking: None (Open Label)
Primary purpose: Screening
Keywords: hypothermia; vasoconstriction threshold; propofol; remimazolam