Effect of Controlled Hypotension on Cerebral Oxygen Saturation

NCT02967029 | Completed Phase 4

• 1 other identifier: IstanbulUn
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

For a successful functional endoscopic sinus surgery (FESS), it is crucial to provide effective controlled hypotension to reduce blood loss and provide a relatively blood-free surgical environment to facilitate surgery. The goal of controlled hypotension is to maintain an arterial blood pressure which is sufficiently low to allow a reduction in bleeding with offering a superior intraoperative hemodynamic stability during stressful surgical events to maintain intact cerebral microcirculatory auto-regulation. Auto-regulation impairment during controlled hypotension might increase oxygen extraction ratio. Thus monitoring the cerebral oxygen saturation (rSO2) to measure cerebral oxygenation becomes essential and it remains a challenge to clinically assess cerebral oxygenation on a routine basis. Various recent studies reported based on facilitating the induction of controlled hypotension, but the effects of hypotension on cerebral perfusion and oxygenation and its effects on postoperative cognitive function are still poorly characterized. Moreover, the relationship between rSO2 and controlled hypotension has not been established in patients undergoing FESS. Within the last decade, near infrared spectroscopy (NIRS) INVOS® monitors which is clinically most broadly spread technique, can be used for non-invasive assessment of cerebral perfusion by detecting changes in rSO2 by online monitoring of cerebral oxygenation. In our clinical routine for achieving a controlled hypotension, esmolol and remifentanyl are the most commonly used hypotensive agents. The aim of this prospective randomized single blind study was to investigate the influence of remifentanyl as a hypotensive agent in comparison to esmolol on rSO2 by using NIRS and postoperative cognitive function in patients undergoing FESS.

Conditions

Hypotension Drug-Induced; Cerebral Oxygen Saturation

Outcome Measures

Primary Outcomes (1)

• cerebral desaturation

  reduction of cerebral oxygen saturation to higher than 20 % of baseline for ≥ 15 seconds were recorded when MAP reached the desired range (50-60 mmHg)

  reduction of cerebral oxygen saturation to higher than 20 % of baseline for ≥ 15 seconds through surgery completion

Secondary Outcomes (10)

• the quality of the surgical field

  When MAP reached the desired range (50-60 mmHg) and was maintained for at least 10 minutes

• Arterial blood pressure

  arterial blood pressure at baseline, after induction, peroperative and 5 and 10 minutes after stoppage of hypotensive agents through surgery completion

• Heart rate

  Heart rate at baseline, after induction, peroperative and 5 and 10 minutes after stoppage of hypotensive agents through surgery completion

• SPO2 value

  SPO2 value at baseline, after induction, peroperative and 5 and 10 minutes after stoppage of hypotensive agents through surgery completion

• cognitive function of the patients

  cognitive function of the patients were assessed 1 hour before surgery and 120 minutes after the discontinuation of the drugs

Study Arms (2)

b group

ACTIVE COMPARATOR

b group controlled hypotension with esmolol hydrochloride

Drug: Esmolol Hydrochloride

r group

ACTIVE COMPARATOR

r group controlled hypotension with remifentanil hydrochloride

Drug: Remifentanil Hydrochloride

Interventions

Esmolol Hydrochloride DRUG

the influence of brevibloc as a hypotensive agent on rSO2

Also known as: Brevibloc 10 MG/ML Injectable Solution

b group

Remifentanil Hydrochloride DRUG

the influence of remifentanyl as a hypotensive agent on rSO2

Also known as: ultiva

r group

Eligibility Criteria

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

You may qualify if:

• American Society of Anesthesiology (ASA) I and II patients
• aging between 18 and 65,
• undergoing for elective FESS
• requiring general anesthesia with endotracheal intubation

You may not qualify if:

• hypertension,
• coronary artery diseases and cerebral insufficiency,
• severe hypovolemia and anemia,
• body mass index over 30 kg/m2,
• anticoagulation therapy
• previous hypersensitivity to any of the study drugs

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Department of Anesthesiology

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypotension

Interventions

esmolol; Remifentanil

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Demet Altun

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending anesthesiologist

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: November 17, 2016
• Study Start: November 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: August 1, 2017
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)