Comparison of the Effect of Remimazolam With Sevoflurane on Postanesthetic Shivering

NCT05523037 | Completed DMC

• 1 other identifier: WonkwangUH10
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of postanesthetic shivering (PAS) after general anesthesia is affected by the anesthesia maintenance agents. This study compared the effect of remimazolam with sevoflurane on PAS in patients with laparoscopic gynecologic surgery under general anesthesia.

Conditions

Anesthesia; Hypothermia

Keywords

shivering; general anesthesia; laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• The incidence of postanesthetic shivering (PAS)

  In the recovery room, an attending anesthesiologist observed shivering. The severity of PAS was assessed with a bedside shivering assessment scale, which rated shivering as None (Grade 0): no shivering noted on palpation of the masseter, neck, or chest wall, Mild (Grade 1): shivering localized to the neck and/or thorax only, Moderate (Grade 2): shivering involved gross movement of the upper extremities (in addition to neck and thorax) and Severe (Grade 3): shivering involved gross movements of the trunk and upper and lower extremities

  during staying in recovery room

Secondary Outcomes (4)

• The severity of PAS

  during staying in recovery room

• Mean arterial pressure (MAP)

  during general anesthesia

• Heart rate (HR)

  during general anesthesia

• Core body temperature

  during general anesthesia

Study Arms (2)

Group S

Anesthesia induction was achieved by continuous infusion of 6 mg/kg/h of remimazolam, and the maintenance of anesthesia was maintained at a BIS between 40 and 60. For the maintenance of anesthesia, the end-tidal concentration of 1 minimum alveolar concentration (MAC) sevoflurane was administered

Drug: Sevoflurane

Group R

Anesthesia induction was achieved by continuous infusion of 6 mg/kg/h of remimazolam, and the maintenance of anesthesia was maintained at a BIS between 40 and 60. For the maintenance of anesthesia, 1-2 mg/kg/h of remimazolam was continuously infused.

Drug: Remimazolam

Interventions

Sevoflurane DRUG

For the maintenance of anesthesia, the end-tidal concentration of 1 minimum alveolar concentration (MAC) sevoflurane and the concentration was adjusted by 1% stepwise titration

Group S

Remimazolam DRUG

For the maintenance of anesthesia, 1-2 mg.kg-1.h-1 of remimazolam was continuously infused.

Also known as: Byfavo®

Group R

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients aged between 19 and 65 y, with ASA physical status classes I or II, who undergoing laparoscopic gynecologic surgery

You may qualify if:

• patients aged between 19 and 65 y, with ASA physical status classes I or II

You may not qualify if:

• Patients with history such as thyroid disease, cardiopulmonary disease, blood coagulation disorder, liver dysfunction, cranial nerve disease, alcohol or drug abuse, a known allergy to the study drug, and those who had core body temperature \> 38°C or \< 36.5°C, BMI \> 30 kg.m-2 or febrile illness were excluded. Patients who underwent surgery for less than 60 min, and those who did not consent to this study

Sponsors & Collaborators

• Wonkwang University Hospital: lead

Study Sites (1)

Wonkwag UH

Iksan, Jeollabukdo, 54538, South Korea

Location

MeSH Terms

Conditions

Hypothermia

Interventions

Sevoflurane; remimazolam

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 31, 2022
• Study Start: January 2, 2022
• Primary Completion: July 30, 2022
• Study Completion: August 15, 2022
• Last Updated: August 31, 2022

Record last verified: 2022-08

Locations

KR (1)