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NCT Number: NCT05523037

Comparison of the Effect of Remimazolam With Sevoflurane on Postanesthetic Shivering

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.

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Key information

Conditions

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

Age range

19 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Wonkwag UH

Iksan, Jeollabukdo, 54538, South Korea

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Remimazolam

Drug

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

Other names: Byfavo®

Primary outcomes

  1. The incidence of postanesthetic shivering (PAS)

    Time frame: during staying in recovery room

    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

Secondary outcomes

  1. The severity of PAS

    Time frame: during staying in recovery room

    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

  2. Mean arterial pressure (MAP)

    Time frame: during general anesthesia

    MAP was checked at pre-induction, and after induction, every 10 minutes until the end of surgery.

  3. Heart rate (HR)

    Time frame: during general anesthesia

    HR was checked at pre-induction, and after induction, every 10 minutes until the end of surgery.

  4. Core body temperature

    Time frame: during general anesthesia

    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.

Sponsors and collaborators

Lead sponsor

Wonkwang University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 31, 2022
Registry last updated
Aug 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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