The Comparison of Hemodynamic Effects Between Remimazolam-remifentanil and Propofol-remifentanil in Patients Undergoing Laparoscopic Cholecystectomy
Overview
- Phase
- Not Applicable
- Intervention
- propofol group
- Conditions
- Acute Cholecystitis
- Sponsor
- Yonsei University
- Enrollment
- 274
- Locations
- 1
- Primary Endpoint
- Percent of patients with hypotension event
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This study is conducted to determine whether the occurrence of hypotension is reduced by the combined use of remimazolam and remifentanil compared to the conventional combination use of propofol and remifentanil. Patients enrolled in the study are infused continuously with either propofol or remimazolam from the start of anesthesia to the end of surgery.
Investigators
Eligibility Criteria
Inclusion Criteria
- •patients 19 years of age or older
- •the American Society of Anesthesiologists classification 1-3
- •patients undergoing laparoscopic cholecystectomy at Severance Hospital
Exclusion Criteria
- •Emergency surgery,
- •patients with heart disease or arrhythmias,
- •patients undergoing concurrent surgery other than laparoscopic cholecystectomy,
- •obesity (BMI\>30),
- •patients who were admitted on the surgery day,
- •foreigners,
Arms & Interventions
propofol group
During induction, the propofol group starts the effect site concentration at 4.0 ng/ml with TCI and adjusts it to around 3.0 \~ 4.0 ng/ml after intubation to maintain an appropriate EEG-based depth of anesthesia.
Intervention: propofol group
remimazolam group
Arm Description: In the remimazolam group, start remimazolam at 6 mg/kg/hr and adjust it to 1 mg/kg/hr after loss of consciousness to maintain an appropriate EEG-based depth of anesthesia.
Intervention: remimazolam group
Outcomes
Primary Outcomes
Percent of patients with hypotension event
Time Frame: from start of drugs to end of anesthesia on the surgery 1 day
Secondary Outcomes
- difference of QOR-40 score(Baseline (preoperative period) and Postoperative day 1)
- time-weighted average of hypotension(from start of drugs to end of anesthesia on the surgery 1 day)
- dose of Norepinephrine or nicardipine(from start of drugs to end of anesthesia on the surgery 1 day)
- Heart rate variability(from start of drugs to end of anesthesia on the surgery 1 day)
- Sedline(Psi)(from start of drugs to end of anesthesia on the surgery 1 day)