Comparison of the Effects of Nicardipine and Remifentanil on Surgical Visual Field
- Conditions
- Other Complications of Surgical and Medical Procedures
- Registration Number
- NCT06130527
- Lead Sponsor
- Erol Karaaslan
- Brief Summary
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).
- Detailed 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 64
- ASA I-II patients of both sexes,
- aged 18-65 years,
- scheduled for tympanomastoidectomy and decided to perform CH,
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Quality of the intraoperative surgical field Measurements will be made at four different times B1: Skin incision (initial stage of surgery), B2: mastodectomy stage of surgical intervention, B3: cholestatum cleaning stage of surgical intervention, B4: grafting phase of surgical intervention Quality of the intraoperative surgical field will be measured on a grade of 0-10 (0-1. no bleeding, 2-3. mild bleeding, 4-5. Mild to moderate bleeding, 6-7. moderate bleeding, 8-9. moderate to severe bleeding, 10. Severe bleeding)
- Secondary Outcome Measures
Name Time Method Heart rate Measurements will be made at six different times T1: at the 20th minute of surgical intervention T2: mastodectomy stage of intervention T3: cholestatum clearing of intervention T4: grafting phase of surgical T5: first minute after extubation, T6: 10 min Heart rate is measured as beats/minute on the anesthesia monitor
Mean arterial pressure Measurements will be made at six different times T1: at the 20th minute of surgical intervention T2: mastodectomy stage of intervention T3: cholestatum clearing of intervention T4: grafting phase of surgical T5: first minute after extubation, T6: 10 min Mean arterial pressure is measured as mmHg on the anesthesia monitör