Wonkwag UH
Iksan, Jeollabukdo, 54538, South Korea
NCT Number: NCT05574257
After dividing the patients into two groups, sedation is performed with propofol and remimazolam, respectively, after spinal anesthesia. Compare the patient's body temperature change after surgery.
Looking for future studies?
Notify Me19 year–65 year
All sexes
Interventional
Not applicable
Iksan, Jeollabukdo, 54538, South Korea
Patients in the study were randomly assigned to the propofol group (Group P) and the remimazolam group (Group R) in a 1:1 ratio. Study drugs are prepared in the same 50 ml syringe, double-blind to group assignment. All patients are not given pre-anesthetic medication, and body temperature, blood pressure, and heart rate are measured in the recovery room after surgery at 10-minute intervals from just before anesthesia induction to surgery. If hypotension or bradycardia occurs during surgery and is not corrected even after rapid fluid infusion, ephedrine is increased by 10 mg or glycopyrrolate 0.2 mg or atropine 0.5 mg is administered.
If spinal anesthesia is successfully performed, check the patient's anesthesia height. When the appropriate level of anesthesia is confirmed, Group P receives propofol at 25-100ug/kg/min and maintains the BIS at 70-80. Group R receives remimazolam at 1-20ug/kg/min and maintains BIS between 70-80. Both groups apply a conventionally used air heating device, and the operating room temperature is kept at 20 °C. If shivering occurs during surgery, the elapsed time from induction and the shivering grades are recorded.
At the end of the surgery, record total anesthesia time and surgery time, fluid dose, and drug use. After moving to the recovery room, the patient's body temperature, systolic blood pressure, diastolic pressure, heart rate, the incidence of shivering, and the grade of shivering are checked. When shivering occurs, a forced air-warming device is applied first, and if shivering continues, administer meperidine in 5mg increments until the patient is comfortable and record the total dose.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Propofol is injected at 25-100ug/kg/min (immediately after spinal anesthesia to the end of surgery) to maintain the BIS at 70-80.
Other names: Fresofol®
Remimazolam is injected at 1-20ug/kg/min (immediately after spinal anesthesia to the end of surgery) to maintain the BIS at 70-80.
Other names: Byfavo®
Time frame: During surgery
Measure the body temperature on the tympanic membrane three times and enter the highest value.
Time frame: At PACU (Post Anesthesia Care Unit)
measure the body temperature three times on the tympanic membrane and enter the highest value.
Time frame: Before the induction of anesthesia
Every 10 minutes, measure the body temperature three times on the tympanic membrane and enter the highest value.
Time frame: During surgery
Every 10 minutes, measure the body temperature three times on the tympanic membrane and enter the highest value.
Time frame: At PACU
Every 10 minutes, measure the body temperature three times on the tympanic membrane and enter the highest value.
Time frame: During surgery
Time frame: At PACU
Wonkwang University Hospital
Other
Comparison of the Effect of Remimazolam and Propofol on Perioperative Hypothermia Under Spinal Anesthesia: A Randomized Control Study.
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.
Published trials that share one or more normalized conditions with this study.
NCT07395947
Functional Balance, Lower Extremity Problem
Adana, Turkey (Türkiye)
View Trial DetailsNCT06555198
Foot Deformities, Lower Extremity Problem
Turku, Southwest Finland, Finland
View Trial DetailsNCT06548087
Ambulation Difficulty, Lower Extremity Problem
Baltimore, Maryland, United States
View Trial DetailsNCT05442879
Anterior Cruciate Ligament Injuries, Knee Injuries
Flint, Michigan, United States
View Trial Details