Comparison of the Effects of Remifentanil and Dexmedetomidine Administered Under General Anesthesia in Rhinoplasty
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Baskent University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Mean arterial pressure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Other
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients who will have rhinoplasty surgery American Society of Anesthesiologists (ASA) I- II class
Exclusion Criteria
- •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
Arms & Interventions
Group Remifentanil
Remifentanil group was initially to receive remifentanil (group R), 0.01-0.2 g/kg/min without intraoperative loading.
Intervention: Remifentanil 2 MG (Drug)
Group 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.
Intervention: dexmedetomidine (Drug)
Outcomes
Primary Outcomes
Mean arterial pressure
Time Frame: During surgery
The investigators compare the stability of mean arterial pressure.
Postoperative pain
Time Frame: 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
Time Frame: 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 Outcomes
- Postoperative nausea and vomiting scores(postoperative first 6 hours and 24 hours)
- Patient satisfaction(Postoperative 6. hours)
- Surgeon satisfaction(Postoperative 0. hours)
Investigators
Zeynep Ersoy
Assistant professor
Baskent University