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NCT Number: NCT05574257

Comparison of the Effect of Remimazolam and Propofol on Perioperative Hypothermia Under Spinal Anesthesia

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.

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Key information

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wonkwag UH

Iksan, Jeollabukdo, 54538, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Those aged between 19 and under 65 who are undergoing surgery under spinal anesthesia at Wonkwang University Hospital.
  • American Society of Anesthesiologists' physical status class (ASA) award class I-III.

Exclusion criteria

  • Patients with fever before surgery
  • Patients taking antipyretics before surgery
  • Patients who are chronically using anti-inflammatory drugs
  • High-risk patients with ASA class IV or higher
  • Patient who refused sedation
  • Patients with thyroid dysfunction.

Treatment and study plan

Propofol

Drug

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

Drug

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®

Primary outcomes

  1. The incidence of perioperartive hypothermia

    Time frame: During surgery

    Measure the body temperature on the tympanic membrane three times and enter the highest value.

  2. The incidence of perioperartive hypothermia

    Time frame: At PACU (Post Anesthesia Care Unit)

    measure the body temperature three times on the tympanic membrane and enter the highest value.

Secondary outcomes

  1. core body temperature

    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.

  2. core body temperature

    Time frame: During surgery

    Every 10 minutes, measure the body temperature three times on the tympanic membrane and enter the highest value.

  3. core body temperature

    Time frame: At PACU

    Every 10 minutes, measure the body temperature three times on the tympanic membrane and enter the highest value.

  4. shivering grades

    Time frame: During surgery

    • 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 the gross movement of the upper extremities (in addition to neck and thorax)
    • Severe (Grade 3): shivering involved gross trunk and upper and lower extremities movements.
  5. shivering grades

    Time frame: At PACU

    • 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 the gross movement of the upper extremities (in addition to neck and thorax)
    • Severe (Grade 3): shivering involved gross trunk and upper and lower extremities movements.

Sponsors and collaborators

Lead sponsor

Wonkwang University Hospital

Other

Registry information

Official study title

Comparison of the Effect of Remimazolam and Propofol on Perioperative Hypothermia Under Spinal Anesthesia: A Randomized Control Study.

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 10, 2022
Registry last updated
Oct 10, 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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