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The Comparison of Remimazolam With Propofol in Core Body Temperature

Primary Purpose

Hypothermia; Anesthesia

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Remifentanil
Sponsored by
Wonkwang University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hypothermia; Anesthesia focused on measuring hypothermia, vasoconstriction threshold, propofol, remimazolam

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Wonkwag UH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

PR group

RR group

Arm Description

Propofol and Remifentanil group

Remimazolam and Remifentanil group

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
December 26, 2021
Last Updated
January 28, 2022
Sponsor
Wonkwang University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05215834
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wonkwang University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia; Anesthesia
Keywords
hypothermia, vasoconstriction threshold, propofol, remimazolam

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized and cohort study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PR group
Arm Type
Active Comparator
Arm Description
Propofol and Remifentanil group
Arm Title
RR group
Arm Type
Experimental
Arm Description
Remimazolam and Remifentanil group
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Other Intervention Name(s)
propofol or remimazolam
Intervention Description
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.
Primary Outcome Measure Information:
Title
core body temperature change (°C)
Description
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
Time Frame
at 60 minutes after induction of general anesthesia
Secondary Outcome Measure Information:
Title
times to onset of vasoconstriction (minute)
Description
time to arrive the skin temperature gradient (between forearm and index finger tip) equaled 0 °C.
Time Frame
From after induction to until the end of surgery
Title
intraoperative hypothermia
Description
core body temperature of <36 °C in patients undergoing anesthesia and surgery
Time Frame
From after induction to until the end of surgery
Title
Mean arterial pressure (mmHg)
Description
Mean arterial pressure
Time Frame
From after induction to until the end of surgery
Title
Heart rate (beats/min)
Description
Heart rate
Time Frame
From after induction to until the end of surgery
Title
vasoconstriction threshold (°C)
Description
the tympanic membrane temperature at which the skin temperature gradient (between forearm and index finger tip) equaled 0 °C
Time Frame
From after induction to until the end of surgery

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheol Lee, M.D.,Ph.D
Organizational Affiliation
Department of anesthesiology and pain medicine, Wonkwang University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wonkwag UH
City
Iksan
ZIP/Postal Code
54538
Country
Korea, Republic of

12. IPD Sharing Statement

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The Comparison of Remimazolam With Propofol in Core Body Temperature

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