Combining Sevoflurane and Remimazolam for Faster Recovery After Gynecological Surgery
Effect of Combined Administration of Sevoflurane and Remimazolam on Emergence in Patients Undergoing Gynecological Laparoscopic Surgery Under General Anesthesia: a Prospective Randomized Controlled Study
This study is testing if using a mix of two anesthetics, sevoflurane and remimazolam, can help adults recover faster after gynecological surgeries like hysterectomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 19 Years to 70 Years |
| Sex | Female |
| Sponsor | Pusan National University Yangsan Hospital Academic / other |
| Locations | 1 site (Yangsan) |
| Trial ID | NCT06385002 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of administering sevoflurane in combination with remimazolam on the recovery time of adult patients undergoing gynecological surgeries such as laparoscopic oophorectomy or hysterectomy. The research aims to compare the time to emergence from anesthesia and tracheal extubation between the combined administration of these anesthetics versus sevoflurane alone. Enhanced recovery after surgery (ERAS) protocols are being explored to improve patient outcomes, and this study seeks to determine if the combination can lead to quicker recovery and reduced postoperative complications. The study will include adult patients classified as ASA physical status I or II.
Who should consider this trial
Good fit: Ideal candidates are adult patients aged 19 to 70 undergoing gynecologic and laparoscopic surgery under general anesthesia.
Not a fit: Patients classified as ASA physical status III or above, pregnant women, or those with hypersensitivity to sevoflurane may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to faster recovery times and improved patient satisfaction after gynecological surgeries.
How similar studies have performed: While studies have shown success with similar anesthetic combinations in other populations, this specific approach has not yet been tested in adult gynecological surgery patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients aged 19 to 70 undergoing gynecologic and laparoscopic surgery under general anesthesia * Patients classified as American Society of Anesthesiologists (ASA) physical status classification I or II * According to the American Society of Anesthesiologists (ASA) physical status classification: Class I - Healthy patients without systemic disease Class II - Patients with mild systemic disease without functional limitation Class III - Patients with severe systemic disease that limits activity but is not incapacitating Class IV - Patients with incapacitating systemic disease that is a constant threat to life Class V - Moribund patients who are not expected to survive without the operation Class VI - Brain-dead patients for organ donation Exclusion Criteria: * Patients classified as ASA physical status classification III or above * Pregnant women * Patients with hypersensitivity to sevoflurane or other halogenated anesthetics, malignant hyperthermia, or a history of it in the patient or family * Patients with preoperative impairment of consciousness or coma * Patients undergoing emergency surgery or those who are hemodynamically unstable preoperatively * Patients with a history of neuromuscular disorders or medication affecting neuromuscular function * Patients who have taken sedatives (anxiolytics, hypnotics, antipsychotics, antidepressants, or sleeping pills) within 24 hours * Patients receiving long-term benzodiazepine therapy * Patients with alcohol or substance dependence * Patients with allergy history to benzodiazepines or flumazenil * Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption * Patients with severe hypersensitivity reactions to dextran 40 * Patients with chronic renal failure requiring hemodialysis * Patients with a history of acute angle-closure glaucoma
Where this trial is running
Yangsan
- Pusan National University Yangsan Hospital — Yangsan, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Hee Young Kim, MD, PhD — Department of Anesthesia and Pain Medicine, School of Medicine, Pusan National University
- Study coordinator: Hee Young Kim
- Email: yuvi1981@naver.com
- Phone: 82553602129
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.