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

Dexmedetomidine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05572723
• Other study ID #: KA 22/12
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2022
• Est. completion date: July 31, 2022

Study information

• Verified date: October 2022
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 31, 2022
• Est. primary completion date: July 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dexmedetomidine
• Remifentanil
• Rhinoplasty

Intervention

Drug:
• Remifentanil 2 MG
Remifentanil is an opioid; it has sedative, analgesic, and sympatholytic properties.
• 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.

Locations

Country	Name	City	State
Turkey	Baskent University Medical School	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean arterial pressure	The investigators compare the stability of mean arterial pressure.	During surgery
Primary	Postoperative pain	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).	Up to 30 minutes after the patient wakes up.
Primary	Patient Recovery Time	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.	Postoperative 1. hours
Secondary	Postoperative nausea and vomiting scores	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).	postoperative first 6 hours and 24 hours
Secondary	Patient satisfaction	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).	Postoperative 6. hours
Secondary	Surgeon satisfaction	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).	Postoperative 0. hours