Comparison of the Effects of Nicardipine and Remifentanil on Surgical Visual Field

Erol Karaaslan

Status: Not yet enrolling

Conditions: Other Complications of Surgical and Medical Procedures

Treatments: Procedure: Nicardipine; Procedure: Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT06130527

erolkaraaslan5

Details and patient eligibility

About

In the present study, the purpose was to compare the effects of Nicardipine and Remifentanil on surgical visual field and hemodynamic parameters in microscopic tympanomastoidectomy cases with Controlled Hypotension (CH).

Full description

The visibility of the surgical field provides many advantages (e.g., preventing possible complications and reducing the duration of surgical application). In microsurgery performed in a closed and narrow area (e.g., middle ear surgery), even a small amount of blood may impair the quality of vision in the operation area and complicate the surgical intervention.

Controlled Hypotension (CH) is often preferred in some planned surgeries in reducing intraoperative bleeding, creating a quality surgical field, increasing surgical success, and reducing surgical complications. It is especially important to use it in interventions such as Functional Endoscopic Sinus Surgery (FESS), septoplasty, tympanoplasty, and vertebral surgery performed with microsurgery. As well as the advantages of CH, there is the possibility of causing various side effects by causing target organ hypoperfusion. Cerebral, renal, liver, and cardiovascular systems are the organs most affected by side effects.

Various hypotensive agents such as volatile anesthetics, sympathetic antagonists, sodium nitroprusside, nitroglycerin, hydralazine, trimethaphan, and α2 agonists are used in the literature to provide controlled hypotension.

Nicardipine is a dihydropyridine derivative vasoselective drug. Rapid onset of action i.v. nicardipine is used when rapid control of blood pressure is needed. The potential role of i.v. nicardipine was shown in many cardiovascular and neurovascular surgical procedures and surgical procedures in which CH was performed with hemostasis.

Its dromotropic effect is very low because nicardipine has no significant depressant effect on the conduction system and electrophysiological parameters of the heart. It undergoes substantial presystemic elimination in the liver after oral administration. For this reason, the rate of elimination does not change in patients with kidney failure. The elimination half-life is approximately 2 hours and slows down in patients with hepatic dysfunction.

Many studies investigate the effects of CH on surgical field image quality, surgical satisfaction, bleeding, and hemodynamic parameters. However, in our literature review, no study was detected comparing Nicardipine and Remifentanil in microscopic tympanomastoidectomy cases.

In the present study, the purpose was to compare the effects of controlled hypotension with nicardipine and remifentanil on the quality of surgical field visibility and hemodynamic parameters in endoscopic tympanomastoidectomy cases

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA I-II patients of both sexes,
• aged 18-65 years,
• scheduled for tympanomastoidectomy and decided to perform CH,

Exclusion criteria

• hypertension,
• anticoagulant medication,
• pregnancy
• major hepatic,
• renal,
• cerebral, or cardiorespiratory dysfunction,
• neurological or psychiatric disease
• ASA 3-4,
• Body Mass Index BMI≥35 kg/m2,
• difficult intubation was considered (Mallampati score 3-4, a thyromental distance less than 6 cm, maximum mouth opening less than 3 cm),
• the number of intubation attempts more than two, cases with allergies to any of the agents used in the study

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups

Nicardipine

Active Comparator group

Description:

Nicardipine is a dihydropyridine derivative vasoselective drug. Rapid onset of action i.v. nicardipine is used when rapid control of blood pressure is needed. The potential role of i.v. nicardipine was shown in many cardiovascular and neurovascular surgical procedures and surgical procedures in which CH was performed with hemostasis (6).

Treatment:

Procedure: Nicardipine

Remifentanil

Active Comparator group

Description:

Although remifentanil has unique pharmacokinetic properties, its pharmacodynamic effects are similar to those of other opioids. Remifentanil has dose-dependent analgesic, sedation and respiratory suppression side effects. All of these effects are antagonized by the mu receptor-specific opioid antagonist naloxone. Remifentanil has vagotonic and sympatholytic effects, and common side effects are bradycardia (heart rate \<50 beats/min) and hypotension (SBP \<80 mm Hg). Other common side effects are itching, nausea and vomiting, and chest wall stiffness after bolus administration (35). The elderly population is more sensitive to opioid effects. It has been shown that it suppresses the delta wave in EEG due to the effects of opioids in the cerebral cortex. This feature is twice as common in the elderly as in the younger population.

Treatment:

Procedure: Remifentanil