Anesthesia; HypothermiaNCT05523037
Comparison of the Effect of Remimazolam With Sevoflurane on Postanesthetic Shivering
An observational study of Anesthesia; Hypothermia, run by Wonkwang University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 65 years, women only
- Conditions the study is for
- Anesthesia; Hypothermia
- What is being tested?
- Sevoflurane and Remimazolam
- Type of treatment
- Injection or infusion
- How many people
- 74 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jan 2022to 15 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- Women only
- Adult, Older adult
Study population: patients aged between 19 and 65 y, with ASA physical status classes I or II, who undergoing laparoscopic gynecologic surgery
Who may be able to join
- patients aged between 19 and 65 y, with ASA physical status classes I or II
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Anesthesia; Hypothermia
- Being tested
- Sevoflurane, Remimazolam
- Keywords
- shivering, general anesthesia, laparoscopic surgery
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
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
RemimazolamDrug
Also called Byfavo®
For the maintenance of anesthesia, 1-2 mg.kg-1.h-1 of remimazolam was continuously infused.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during staying in recovery room
Secondary outcomes (4)
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
Measured: during staying in recovery room
Mean arterial pressure (MAP)
MAP was checked at pre-induction, and after induction, every 10 minutes until the end of surgery.
Measured: during general anesthesia
Heart rate (HR)
HR was checked at pre-induction, and after induction, every 10 minutes until the end of surgery.
Measured: during general anesthesia
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.
Measured: during general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start2 Jan 2022
- Primary completion30 Jul 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia; HypothermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wonkwang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheol Lee,MD,PhD,, Wonkwang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523037
- Sponsor's protocol ID
- WonkwangUH10
- Status last verified
- Aug 2022
- First submitted
- 25 Aug 2022
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05523037
- Acronym / sponsor ID
- WonkwangUH10
- Conditions
- Anesthesia; Hypothermia
- Keywords
- shivering, general anesthesia, laparoscopic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Wonkwang University HospitalUniversity, hospital or other
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group S | – | Drug: SevofluraneAnesthesia 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 |
| Group R | – | Drug: RemimazolamAnesthesia 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. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- patients aged between 19 and 65 y, with ASA physical status classes I or II, who undergoing laparoscopic gynecologic surgery
Key inclusion criteria (1 listed)
- patients aged between 19 and 65 y, with ASA physical status classes I or II
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevofluraneFor the maintenance of anesthesia, the end-tidal concentration of 1 minimum alveolar concentration (MAC) sevoflurane and the concentration was adjusted by 1% stepwise titration | Drug | Group S |
| RemimazolamAlso: Byfavo®For the maintenance of anesthesia, 1-2 mg.kg-1.h-1 of remimazolam was continuously infused. | Drug | Group R |
Primary outcome
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
4 secondary outcomes
The severity of PAS
Time frame: during staying in recovery room
Mean arterial pressure (MAP)
Time frame: during general anesthesia
Heart rate (HR)
Time frame: during general anesthesia
Core body temperature
Time frame: during general anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia; Hypothermia, run by Wonkwang University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postanesthetic shivering (PAS) (time frame: during staying in recovery room). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022.