Comparison of the Effects of Remifentanil and Dexmedetomidine Administered Under General Anesthesia in Rhinoplasty
- Conditions
- DexmedetomidineRemifentanilRhinoplasty
- Interventions
- Registration Number
- NCT05572723
- Lead Sponsor
- Baskent University
- Brief Summary
The investigators compared the effects of remifentanil and dexmedetomidine administered under general anesthesia on hemodynamics, postoperative pain, recovery, postoperative nausea, vomiting, shivering, patient's and surgeon's satisfaction in patients undergoing elective rhinoplasty. A single-center, prospective, blinded, randomized controlled trial. After the approval of the hospital ethics committee (KA22/12), fifty volunteers aged 18-65 years who underwent rhinoplasty under elective conditions accepted the study in the American Society of Anesthesiologists (ASA) I-III class. The patients were randomly divided into the remifentanil group (group R) and the dexmedetomidine group (group D). Group R (n=25) was initially to receive remifentanil 0.01-0.2 g/kg/min without intraoperative loading. Group D (n=25) dexmedetomidine, was initiated with a bolus of 1 mg/kg and received 0.2-0.7 g/kg per hour as an infusion during surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Patients who will have rhinoplasty surgery American Society of Anesthesiologists (ASA) I- II class
Patients with end-stage liver or kidney disease Uncontrolled hypertension Any type of atrioventricular block, pacemaker Heart failure Diabetes mellitus Chronic obstructive or interstitial lung disease, severe asthma Neurological or psychiatric disease, substance abuse Pregnant or lactating women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Group Remifentanil Remifentanil 2 MG Remifentanil group was initially to receive remifentanil (group R), 0.01-0.2 g/kg/min without intraoperative loading. Group Dexmedetomidine dexmedetomidine Dexmedetomidine group, dexmedetomidine (group D) was initiated with a bolus of 1 mg/kg and received 0.2-0.7 g/kg per hour as an infusion during surgery.
- Primary Outcome Measures
Name Time Method Mean arterial pressure During surgery The investigators compare the stability of mean arterial pressure.
Postoperative pain Up to 30 minutes after the patient wakes up. The investigators compare the effect of remifentanil and dexmedetomidine on postoperative pain. The patients pain level was assessed using the numeric pain scale (Between 0-10, 0 = no pain, 10 = worst pain).
Patient Recovery Time Postoperative 1. hours The investigators compare the effect of remifentanil and dexmedetomidine on patient recovery time. The recovery time of the patient will be evaluated by calculating the time between extubated and discharged from the postoperative care unit.
- Secondary Outcome Measures
Name Time Method Postoperative nausea and vomiting scores postoperative first 6 hours and 24 hours The investigators compare the effect of remifentanil and dexmedetomidine on nausea and vomiting. The presence of PONV was assessed using the Verbal Descriptor Scale (Between 0-3, 0=no nausea, 1=mild, 2=moderate, 3=severe).
Patient satisfaction Postoperative 6. hours The investigators will question patients' degree of postoperative satisfaction. The patient satisfaction scale was used to assess the surgical outcome (Between 1 - 5, 1 = very poor, 5 = very good).
Surgeon satisfaction Postoperative 0. hours The investigators will question surgeons' degree of satisfaction. The surgical satisfaction scale was used to assess the surgical outcome (Between 1 - 5, 1 = very poor, 5 = excellent).
Trial Locations
- Locations (1)
Baskent University Medical School
🇹🇷Ankara, Turkey