Comparison of the Effect of Remimazolam With Sevoflurane on Postanesthetic Shivering

Anesthesia; Hypothermia Clinical Trial

Official title:

Comparison of the Effect of Remimazolam With Sevoflurane on Postanesthetic Shivering in Patients Undergoing Laparoscopic Gynecologic Surgery Under General Anesthesia-prospective Observational Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05523037
• Other study ID #: WonkwangUH10
• Status: Completed
• Start date: January 2, 2022
• Est. completion date: August 15, 2022

Study information

• Verified date: August 2022
• Source: Wonkwang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Inadvertent perioperative hypothermia and postanesthetic shivering (PAS) are common after anesthesia regardless of anesthesia methods. The incidence of perioperative hypothermia and PAS after general anesthesia has been reported to be 37.5 to 77.2% and 20 to 70%, respectively. Shivering begins when vasoconstriction, a major mechanism to prevent body heat loss, is insufficient. PAS is one of the most common discomforts in the recovery room after general anesthesia. Therefore, PAS is common in hypothermic patients.

Volatile or intravenous anesthetics impair the autonomic thermoregulatory vasoconstriction which usually preserves core body temperature. However, benzodiazepines, such as midazolam, do not significantly impair thermoregulation control, even when used in combination with common opioid doses. Remimazolam, a novel benzodiazepine, has been reported for the thermoregulatory vasoconstriction threshold and onset time of vasoconstriction in terms of core body temperature in patients undergoing robotic-assisted and laparoscopic radical prostatectomy. It decreased the vasoconstriction threshold less than propofol, one of the intravenous anesthetics, and the onset of vasoconstriction was faster than propofol.

Investigators hypothesized that remimazolam reduced the incidence of hypothermia compared to sevoflurane, one of the volatile anesthetics, and eventually lowered the frequency of PAS. Therefore, this study compared the effect of remimazolam with sevoflurane on PAS in patients with laparoscopic gynecologic surgery under general anesthesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: August 15, 2022
• Est. primary completion date: July 30, 2022
• Gender: Female
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anesthesia; Hypothermia
• Hypothermia

Intervention

Drug:
• Sevoflurane
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
• Remimazolam
For the maintenance of anesthesia, 1-2 mg.kg-1.h-1 of remimazolam was continuously infused.

Locations

Country	Name	City	State
Korea, Republic of	Wonkwag UH	Iksan	Jeollabukdo

Sponsors (1)

Lead Sponsor	Collaborator
Wonkwang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The severity of PAS	The severity of PAS was assessed with bedside shivering assessment scale, which rate 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	Mean arterial pressure (MAP)	MAP was checked at pre-induction, and after induction, every 10 minutes until the end of surgery.	during general anesthesia
Secondary	Heart rate (HR)	HR was checked at pre-induction, and after induction, every 10 minutes until the end of surgery.	during general anesthesia
Secondary	Core body temperature	The patient's core body temperature was measured using an infrared tympanic thermometer and the highest temperature among the three measurements was measured before induction of anesthesia and in recovery room. After anesthesia induction, a nasopharyngeal temperature probe was inserted through the nostril to a depth of 9.5 to 10 cm at an appropriate location.	during general anesthesia