Clinical trial NCT06130527: Comparison of the Effects of Nicardipine and Remifentanil on Surgical Visual Field
Official title: Comparison of the Effects of Nicardipine and Remifentanil on Surgical Visual Field and Hemodynamic Parameters in Tympanomastoidectomy Cases
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Other Complications of Surgical and Medical Procedures
Keywords: Surgical visual field
nicardipine
remifentanil
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Prospective Randomized, Placebo-Controlled Clinical Tria
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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

Primary outcomes:
measure: Quality of the intraoperative surgical field
timeFrame: 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
Secondary outcomes:
measure: Heart rate
timeFrame: 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
measure: Mean arterial pressure
timeFrame: 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
Other outcomes:
Locations:
Study officials:
affiliation: Inonu University Medical Faculty , malatya.turkey
name: Erol Karaaslan, assoc prof
role: STUDY_DIRECTOR
References:
citation: Baker AR, Baker AB. Anaesthesia for endoscopic sinus surgery. Acta Anaesthesiol Scand. 2010 Aug;54(7):795-803. doi: 10.1111/j.1399-6576.2010.02259.x. Epub 2010 Jun 16.
citation: Shin S, Lee JW, Kim SH, Jung YS, Oh YJ. Heart rate variability dynamics during controlled hypotension with nicardipine, remifentanil and dexmedetomidine. Acta Anaesthesiol Scand. 2014 Feb;58(2):168-76. doi: 10.1111/aas.12233. Epub 2013 Nov 22.