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NCT Number: NCT05572723

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

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.

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Key information

Conditions

Rhinoplasty Dexmedetomidine Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Remifentanil Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Baskent University Medical School

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanil 2 MG

Drug

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

Dexmedetomidine

Drug

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.

Primary outcomes

  1. Mean arterial pressure

    Time frame: During surgery

    The investigators compare the stability of mean arterial pressure.

  2. 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).

  3. 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

  1. Postoperative nausea and vomiting scores

    Time frame: 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).

  2. Patient satisfaction

    Time frame: 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).

  3. Surgeon satisfaction

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 10, 2022
Registry last updated
Oct 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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