Controlled Hypotension in Rhinoplasty and Septoplasty: Incidence of Cognitive Dysfunction and Delirium

NCT06238973 | Completed

• 1 other identifier: 2023-101
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Controlled hypotension application is a commonly preferred anesthesia practice during surgical procedures, particularly in regions with rich tissue perfusion, aiming to reduce bleeding, enhance surgical field visibility, and mitigate potential complications. Preserving blood flow, especially to the brain, heart, and kidneys, is vital during this method. Previous studies on the subject have primarily focused on short-term effects regarding cognitive impairments, with limited research on the long-term impacts. In our study, we aim to investigate how controlled hypotension application, administered to patients undergoing rhinoplasty or septoplasty surgery, specifically affects cerebral blood flow and its potential consequences on the development of short-term/medium-term/long-term cognitive impairments or delirium in the postoperative period.

Conditions

Hypotension During Surgery

Keywords

controlled hypotension; nasal surgery; post operative cognitive dysfunction; post operative delirium

Outcome Measures

Primary Outcomes (1)

• Post Operative Cognitive Dysfunction with Mini Mental Test

  The assessment of patients' postoperative cognitive function will be conducted initially 24 hours after the surgery, and subsequently on the 7th day and at the 3rd month.

  24 hours

Study Arms (2)

Group Low

ACTIVE COMPARATOR

Group Low will aim to maintain an average arterial pressure in the range of 50-57 mmHg.

Other: Group Low

Group Middle

ACTIVE COMPARATOR

The target is to keep the average arterial pressure within the range of 58-65 mmHg

Other: Group Middle

Interventions

Group Low OTHER

In order to maintain arterial blood pressure within the range of 50-57 mmHg, Sevoflurane at a concentration of 0.5-1 MAC and Remifentanil at a rate of 0.05-0.3 mcg/kg/min will be used. If additional hypotensive agents are required, an infusion of Esmolol at a rate of 25-200 mcg/kg/min will be initiated.

Group Low

Group Middle OTHER

In order to maintain arterial blood pressure within the range of 58-65 mmHg, Sevoflurane at a concentration of 0.5-1 MAC and Remifentanil at a rate of 0.05-0.3 mcg/kg/min will be used. If additional hypotensive agents are required, an infusion of Esmolol at a rate of 25-200 mcg/kg/min will be initiated.

Group Middle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• who will undergo rhinoplasty or septoplasty surgery
• between the ages of 18-65
• classified as ASA class I-II

You may not qualify if:

• Patients with hypertension
• Patients with diabetes mellitus
• Patients with significant cardiac disease
• Patients with vascular disease with lung, kidney, or liver parenchymal diseases
• Patients with a history of cerebrovascular events
• Patients with hypovolemia
• those for whom perioperative controlled hypotension is contraindicated (including emergency surgeries, patients with bleeding diathesis, and those with heart valve disease)

Sponsors & Collaborators

• Hitit University: lead

Study Sites (1)

Hitit University Faculty of Medicince

Çorum, Merkez, 19040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

low mobility group protein 160, rat

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assossiated Professor

Model Details: The group to be designated as Group A will aim to maintain an average arterial pressure in the range of 50-57 mmHg. For Group B, the target is to keep the average arterial pressure within the range of 58-65 mmHg.

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 2, 2024
• Study Start: February 6, 2024
• Primary Completion: May 10, 2024
• Study Completion: August 15, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

TU (1)