The Comparison of Remimazolam With Propofol in Core Body Temperature

NCT05215834 | Completed Phase 4 DMC

• 1 other identifier: WonkwangUH9
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypothermia; Anesthesia

Keywords

hypothermia; vasoconstriction threshold; propofol; remimazolam

Outcome Measures

Primary Outcomes (1)

• 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

  at 60 minutes after induction of general anesthesia

Secondary Outcomes (5)

• times to onset of vasoconstriction (minute)

  From after induction to until the end of surgery

• intraoperative hypothermia

  From after induction to until the end of surgery

• Mean arterial pressure (mmHg)

  From after induction to until the end of surgery

• Heart rate (beats/min)

  From after induction to until the end of surgery

• vasoconstriction threshold (°C)

  From after induction to until the end of surgery

Study Arms (2)

PR group

ACTIVE COMPARATOR

Propofol and Remifentanil group

Drug: Remifentanil

RR group

EXPERIMENTAL

Remimazolam and Remifentanil group

Drug: Remifentanil

Interventions

Remifentanil DRUG

1. 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. 2. 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.

Also known as: propofol or remimazolam

PR group; RR group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wonkwang University Hospital: lead

Study Sites (1)

Wonkwag UH

Iksan, 54538, South Korea

Location

MeSH Terms

Conditions

Hypothermia

Interventions

Remifentanil; Propofol; remimazolam

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Cheol Lee, M.D.,Ph.D

  Department of anesthesiology and pain medicine, Wonkwang University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective randomized and cohort study

Study Record Dates

• First Submitted: December 26, 2021
• First Posted: January 31, 2022
• Study Start: March 1, 2021
• Primary Completion: June 30, 2021
• Study Completion: November 30, 2021
• Last Updated: February 14, 2022

Record last verified: 2022-01

Locations

KR (1)