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NCT Number: NCT05215834

The Comparison of Remimazolam With Propofol in Core Body Temperature

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.

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Key information

Conditions

Hypothermia; Anesthesia Body Temperature Changes Hypothermia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Wonkwag UH

Iksan, 54538, South Korea

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remifentanil

Drug
  • 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

Primary outcomes

  1. core body temperature change (°C)

    Time frame: 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 outcomes

  1. times to onset of vasoconstriction (minute)

    Time frame: 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.

  2. intraoperative hypothermia

    Time frame: From after induction to until the end of surgery

    core body temperature of <36 °C in patients undergoing anesthesia and surgery

  3. Mean arterial pressure (mmHg)

    Time frame: From after induction to until the end of surgery

    Mean arterial pressure

  4. Heart rate (beats/min)

    Time frame: From after induction to until the end of surgery

    Heart rate

  5. vasoconstriction threshold (°C)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Wonkwang University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 31, 2022
Registry last updated
Feb 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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