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

Other Complications of Surgical and Medical Procedures Clinical Trial

Official title:

Comparison of the Effects of Nicardipine and Remifentanil on Surgical Visual Field and Hemodynamic Parameters in Tympanomastoidectomy Cases

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06130527
• Other study ID #: erolkaraaslan5
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 30, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: November 2023
• Source: Inonu University
• Contact: Erol Karaaslan, assoc prof
• Phone: +905322034830
• Email: erkara44[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: December 30, 2023
• Est. primary completion date: December 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Other Complications of Surgical and Medical Procedures

Intervention

Procedure:
• Nicardipine
Following the intubation, the infusion was initiated by using an infusion device (Orchestra Base Primea, Fresenius Kabi) with an i.v. dose of 1.0 µg/kg/min iv in Group N. The targeted MAP was determined as 50-65 mmHg and drug doses were increased until the targeted MAP was achieved In Group N. Nicardipine infusion will be increased by titration in groups with MAP above 65 mm/Hg for more than 5 minutes.
• Remifentanil
Infusion was administered i.v. using an infusion device (Orchestra Base Primea, Fresenius Kabi). In Group R, the dose will start at 0.05 µg/kg/min following intubation. The target MAP was determined as 50-65 mmHg and drug doses will be increased until the target MAP is reached. HR more than 120 seconds and less than 45 beats/min will be considered as bradycardia and the remifentanil dose will be reduced. If response is unsatisfactory, 0.5 mg Atropine i.v. will be implemented. Nicardipine and Remifentanil infusions in groups will be increased by titration if MAP rises above 65 mm/Hg for more than 5 minutes.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Erol Karaaslan

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of the intraoperative surgical field	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)	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	Heart rate	Heart rate is measured as beats/minute on the anesthesia monitor	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
Secondary	Mean arterial pressure	Mean arterial pressure is measured as mmHg on the anesthesia monitör	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