Propofol or Sevoflurane Anesthesia in Egyptian Patients

NCT05289349 | Completed

• 1 other identifier: Propofol/Sevofluran Anesthesia
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed research in this application will investigate postoperative cognitive function, pain index, inflammatory response, and oxidative stress effects of propofol versus sevoflurane anesthetic drugs in patients undergoing elective, non-cardiac abdominal operations under general anesthesia to investigate which of them will significantly maintain better cognitive function, decrease the pain index, inflammatory reaction, and oxidative stress, improve outcome, shorten the postoperative recovery time and reduce length of hospital stay, and consequently the cost of hospital stay.

Conditions

Anesthesia

Keywords

Postoperative Effects.; Propofol; Sevoflurane; Anesthesia

Outcome Measures

Primary Outcomes (4)

• Neuron Specific Enolase (NSE, µg/L)

  Venous blood Level

  1 hour after operation

• S100-β protein, pg/mL

  Venous blood Level

  1 hour after operation

• Matrix Metallo-Proteinase-9 (MMP-9, ng/mL)

  Venous blood Level

  1 hour after operation

• Super Oxide Dismutase (SOD, U/L)

  Venous blood Level

  1 hour after operation

Study Arms (2)

group (P) for propofol

ACTIVE COMPARATOR

propofol 6 mg/kg/h in group P

Drug: Propofol

group (S) for sevoflurane.

ACTIVE COMPARATOR

sevoflurane 1.0-1.5 minimum alveolar concentration (MAC) in group S.

Drug: Sevoflurane

Interventions

Propofol DRUG

Propofol (2 mg/kg) for induction of anesthesia , and ( 6 mg/kg/h) for maintenance of anesthesia

group (P) for propofol

Sevoflurane DRUG

Sevoflurane 1.0-1.5 minimum alveolar concentration (MAC)

Also known as: Sevoflurane inhalant product

group (S) for sevoflurane.

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who will be candidates for elective, major, non-cardiac abdominal operations under general anesthesia with propofol or sevoflurane.
• Patients aged from 21 and older, of either sex.
• Patients with body mass index (BMI) 25 to 35 kg/m².
• Patients belong to the American Society of Anesthesiologist (ASA) physical status I or II.
• Patients should have basically normal preoperative laboratory investigations.

You may not qualify if:

• Patients with mini-mental state examination (MMSE) score \<24 points.
• Patients with significant cardiovascular, cerebrovascular, respiratory, liver, renal, endocrine, blood, or immune diseases.
• Patients with visual or auditory disease, infection, chronic inflammation, disturbance of consciousness, cognitive impairment, or dementia.
• Patients who are on long-term use of sedatives or steroids.
• Alcohol or drug abuse.
• Allergy to any drug will be used in this study.

Sponsors & Collaborators

• Rehab Werida: lead

Study Sites (1)

Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.

Damanhūr, Elbehairah, 31527, Egypt

Location

Related Publications (3)

• Caza N, Taha R, Qi Y, Blaise G. The effects of surgery and anesthesia on memory and cognition. Prog Brain Res. 2008;169:409-22. doi: 10.1016/S0079-6123(07)00026-X.

  PMID: 18394490 BACKGROUND

• Tian HT, Duan XH, Yang YF, Wang Y, Bai QL, Zhang X. Effects of propofol or sevoflurane anesthesia on the perioperative inflammatory response, pulmonary function and cognitive function in patients receiving lung cancer resection. Eur Rev Med Pharmacol Sci. 2017 Dec;21(23):5515-5522. doi: 10.26355/eurrev_201712_13943.

  PMID: 29243798 BACKGROUND

• Zhao Y, Zhang H. Propofol and sevoflurane combined with remifentanil on the pain index, inflammatory factors and postoperative cognitive function of spine fracture patients. Exp Ther Med. 2018 Apr;15(4):3775-3780. doi: 10.3892/etm.2018.5898. Epub 2018 Feb 27.

  PMID: 29563982 BACKGROUND

MeSH Terms

Interventions

Propofol; Sevoflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Rehab H Werida, Ass Prof.

  Damanhour University

  STUDY CHAIR

• Amira Kassem, Ph.D

  Damanhour University

  PRINCIPAL INVESTIGATOR

• Ahmed Shaat, Ph.D.

  Damanhour Teaching Hospital

  PRINCIPAL INVESTIGATOR

• Heba Elwan

  Damanhour University

  PRINCIPAL INVESTIGATOR

• Ahmad Salahuddin, Ph.D

  Damanhour University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: prospective, randomized (1:1), double blind clinical trial

Study Record Dates

• First Submitted: March 13, 2022
• First Posted: March 21, 2022
• Study Start: December 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: April 1, 2023
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)