General Anesthesia and Regional Cerebral Oxygenation inSpine Surgery Prone Position

NCT05148637 | Completed

• 1 other identifier: 34775/7/21
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Elderly patients are reportedly at higher risk of postoperative cognitive dysfunction (POCD).The authors hypothesized that the incidence of POCD would be affected by several factors including, the age of the patient, the degree of cerebral oxygenation, type of anesthesia administered, majority of surgery and the patient position during surgery.The investigators examined the relationship between all the previous parameters and (POCD).

Conditions

Spinal Disease

Outcome Measures

Primary Outcomes (1)

• Assessment of postoperative cognitive function

  Assessment of postoperative cognitive function using mini mental state examination to assess patient's orientation postoperatively by 30-point questionnaire

  7 days

Study Arms (3)

Group I

ACTIVE COMPARATOR

anesthesia maintained by sevoflurane

Drug: Maintenance of general anesthesia by Sevoflurane

Group II

ACTIVE COMPARATOR

anesthesia maintained by desflurane

Drug: Maintenance of general anesthesia by Desflurane

Group III

ACTIVE COMPARATOR

anesthesia maintained by TIVA

Drug: Anesthesia was maintained by inhalational anesthesia (total intravenous anesthesia by lidocaine, propfol and fentanyl infusions)

Interventions

Maintenance of general anesthesia by Sevoflurane DRUG

Anesthesia was maintained by inhalational anesthesia (sevoflurane) titrated by monitoring of patient sensitivity index of the Masimo

Also known as: Sevoflurane

Group I

Maintenance of general anesthesia by Desflurane DRUG

Anesthesia was maintained by inhalational anesthesia (desflurane) titrated by monitoring of patient sensitivity index of the Masimo

Also known as: Desflurane

Group II

Anesthesia was maintained by inhalational anesthesia (total intravenous anesthesia by lidocaine, propfol and fentanyl infusions) DRUG

Anesthesia was maintained by inhalational anesthesia (total intravenous anesthesia by lidocaine, propfol and fentanyl infusions) titrated by monitoring of patient sensitivity index of the Masimo

Also known as: Total intravenous anesthesia

Group III

Eligibility Criteria

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

You may qualify if:

• Patients scheduled for lumbar spinal surgery
• Procedures performed in the prone position

You may not qualify if:

• preexisting neuropsychiatric disorders
• emergency operation
• cardiovascular disease
• respiratory disease
• central nervous system disease
• renal dysfunction
• hepatic dysfunction

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Mona Mohamed Mogahed

Tanta, Elgharbia, Egypt

Location

MeSH Terms

Conditions

Spinal Diseases

Interventions

Sevoflurane; Desflurane

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Ethyl Ethers

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The methods of anesthesia were described to the enrolled patients preoperatively, but the patients were unaware about their group.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Montreal Cognitive Assessment (MoCA) were used to assess cognitive function the day before surgery and seventh postoperative day.

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: December 8, 2021
• Study Start: November 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)