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

NCT06130527 | Unknown

• 1 other identifier: erolkaraaslan5
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Other Complications of Surgical and Medical Procedures

Keywords

Surgical visual field; nicardipine; remifentanil

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (2)

Nicardipine

ACTIVE COMPARATOR

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).

Procedure: Nicardipine

Remifentanil

ACTIVE COMPARATOR

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.

Procedure: Remifentanil

Interventions

Nicardipine PROCEDURE

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.

Nicardipine

Remifentanil PROCEDURE

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.

Remifentanil

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erol Karaaslan: lead

Related 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.

  PMID: 20560885 BACKGROUND

• 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.

  PMID: 24261345 RESULT

MeSH Terms

Interventions

Nicardipine; Remifentanil

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines

Study Officials

• Erol Karaaslan, assoc prof

  Inonu University Medical Faculty , malatya.turkey

  STUDY DIRECTOR

Central Study Contacts

Erol Karaaslan, assoc prof

CONTACT

+905322034830; erkara44@hotmail.com

Ahmet Selim Ozkan, assoc prof

CONTACT

04223410660; aselim.ozkan@inonu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Parallel Assignment Prospective Randomized, Placebo-Controlled Clinical Tria

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: November 14, 2023
• Study Start: November 30, 2023
• Primary Completion: December 25, 2023
• Study Completion: December 30, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share