Clinical trial NCT05523037: Comparison of the Effect of Remimazolam With Sevoflurane on Postanesthetic Shivering
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia; Hypothermia
Keywords: shivering
general anesthesia
laparoscopic surgery
Lead sponsor: Wonkwang University Hospital
Sponsor class: OTHER
First posted: 2022-08-31
Enrollment: 74
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of postanesthetic shivering (PAS)
timeFrame: during staying in recovery room
Secondary outcomes:
measure: The severity of PAS
timeFrame: during staying in recovery room
measure: Mean arterial pressure (MAP)
timeFrame: during general anesthesia
measure: Heart rate (HR)
timeFrame: during general anesthesia
measure: Core body temperature
timeFrame: during general anesthesia
Other outcomes:
Locations:
city: Iksan
country: Korea, Republic of
facility: Wonkwag UH
state: Jeollabukdo
Study officials:
References: