Comparison of the Effect of Remimazolam and Propofol on Perioperative Hypothermia Under Spinal Anesthesia

NCT05574257 | Completed

• 1 other identifier: WonkwangUH12
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

After dividing the patients into two groups, sedation is performed with propofol and remimazolam, respectively, after spinal anesthesia. Compare the patient's body temperature change after surgery.

Conditions

Lower Extremity Problem; Gynecologic Disease; Urinary Tract Disease

Outcome Measures

Primary Outcomes (2)

• The incidence of perioperartive hypothermia

  Measure the body temperature on the tympanic membrane three times and enter the highest value.

  During surgery

• The incidence of perioperartive hypothermia

  measure the body temperature three times on the tympanic membrane and enter the highest value.

  At PACU (Post Anesthesia Care Unit)

Secondary Outcomes (5)

• core body temperature

  Before the induction of anesthesia

• core body temperature

  During surgery

• core body temperature

  At PACU

• shivering grades

  During surgery

• shivering grades

  At PACU

Study Arms (2)

Group P

ACTIVE COMPARATOR

The group received propofol injection at 25-100ug/kg/min (immediately after spinal anesthesia to the end of surgery).

Drug: Propofol

Group R

EXPERIMENTAL

The group received remimazolam injection at 1-20ug/kg/min (immediately after spinal anesthesia to the end of surgery).

Drug: Remimazolam

Interventions

Propofol DRUG

Propofol is injected at 25-100ug/kg/min (immediately after spinal anesthesia to the end of surgery) to maintain the BIS at 70-80.

Also known as: Fresofol®

Group P

Remimazolam DRUG

Remimazolam is injected at 1-20ug/kg/min (immediately after spinal anesthesia to the end of surgery) to maintain the BIS at 70-80.

Also known as: Byfavo®

Group R

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those aged between 19 and under 65 who are undergoing surgery under spinal anesthesia at Wonkwang University Hospital.
• American Society of Anesthesiologists' physical status class (ASA) award class I-III.

You may not qualify if:

• Patients with fever before surgery
• Patients taking antipyretics before surgery
• Patients who are chronically using anti-inflammatory drugs
• High-risk patients with ASA class IV or higher
• Patient who refused sedation
• Patients with thyroid dysfunction.

Sponsors & Collaborators

• Wonkwang University Hospital: lead

Study Sites (1)

Wonkwag UH

Iksan, Jeollabukdo, 54538, South Korea

Location

MeSH Terms

Conditions

Genital Diseases, Female; Urologic Diseases

Interventions

Propofol; remimazolam

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Cheolhyeong Lee, M.D.

  Wonkwang University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology and Pain Medicine

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 10, 2022
• Study Start: February 1, 2022
• Primary Completion: May 30, 2022
• Study Completion: September 2, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)