Comparison of the Effects of Remifentanil and Dexmedetomidine Administered Under General Anesthesia in Rhinoplasty

Sponsor

Baskent University (Other)

Overall Status

Completed

CT.gov ID

NCT05572723

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rhinoplasty Dexmedetomidine Remifentanil	Drug: Remifentanil 2 MG Drug: dexmedetomidine	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Comparison of the Effects of Remifentanil and Dexmedetomidine Administered Under General Anesthesia in Rhinoplasty

Actual Study Start Date :

Mar 1, 2022

Actual Primary Completion Date :

Jul 20, 2022

Actual Study Completion Date :

Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group Remifentanil Remifentanil group was initially to receive remifentanil (group R), 0.01-0.2 g/kg/min without intraoperative loading.	Drug: Remifentanil 2 MG Remifentanil is an opioid; it has sedative, analgesic, and sympatholytic properties.
Active Comparator: 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.	Drug: dexmedetomidine Studies show that dexmedetomidine is superior to currently commonly used remifentanil in terms of intraoperative blood pressure control and postoperative pain. Dexmedetomidine, an alpha-2-adrenoceptor agonist, has sympatholytic, sedative, anesthetic, analgesic, and vasoconstrictor effects. It lowers blood pressure by decreasing plasma norepinephrine and epinephrine levels, thereby reducing intraoperative bleeding. Dexmedetomidine is defined as an analgesic that is now widely used to induce and maintain anesthesia and to control postoperative pain, and is defined as an analgesic that does not cause respiratory depression and neurocognitive impairment. Many studies have shown that the use of perioperative dexmedetomidine reduces the stress response to anesthetic induction and surgery and provides hemodynamic stability.

Arm

Intervention/Treatment

Active Comparator: Group Remifentanil

Remifentanil group was initially to receive remifentanil (group R), 0.01-0.2 g/kg/min without intraoperative loading.

Drug: Remifentanil 2 MG

Remifentanil is an opioid; it has sedative, analgesic, and sympatholytic properties.

Active Comparator: 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.

Drug: dexmedetomidine

Studies show that dexmedetomidine is superior to currently commonly used remifentanil in terms of intraoperative blood pressure control and postoperative pain. Dexmedetomidine, an alpha-2-adrenoceptor agonist, has sympatholytic, sedative, anesthetic, analgesic, and vasoconstrictor effects. It lowers blood pressure by decreasing plasma norepinephrine and epinephrine levels, thereby reducing intraoperative bleeding. Dexmedetomidine is defined as an analgesic that is now widely used to induce and maintain anesthesia and to control postoperative pain, and is defined as an analgesic that does not cause respiratory depression and neurocognitive impairment. Many studies have shown that the use of perioperative dexmedetomidine reduces the stress response to anesthetic induction and surgery and provides hemodynamic stability.

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

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