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AnesthesiaNCT05289349

Propofol or Sevoflurane Anesthesia in Egyptian Patients

A study testing Propofol and Sevoflurane in people with Anesthesia, run by Rehab Werida at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 to 75 years
Conditions the study is for
Anesthesia
What is being tested?
Propofol and Sevoflurane
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteEgypt
Study dates
1 Dec 2021to 1 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.

    Damanhūr, Elbehairah, 31527

Other trials in Egypt

About this study

Official title: Postoperative Effects of Propofol or Sevoflurane Anesthesia in Egyptian Patients

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.

Read the detailed description
  1. Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University.
  2. Ethical committee approval will be obtained from Ethics committee of General Organization for Teaching Hospitals and Institutes.
  3. About 44 patients who are candidate for elective, non-cardiac abdominal surgery under general anesthesia with either propofol infusion or sevoflurane inhalation, will be recruited from Damanhour Teaching Hospital, General Organization for Teaching Hospitals and Institutes.
  4. All participants should agree to take part in this clinical study and will provide informed consent.
  5. Demographic data; age (year), sex (female/male), weight (kg), height (cm), BMI (kg/m2) will be collected.
  6. ASA physical status will be recorded.
  7. Venous blood samples (5 ml will be collected by a sterile syringe then placed in a suitable sterile tube to be centrifuged, the serum will be reserved and stored at -80°C until the analysis) before, and 1 hour after operation for evaluating cognitive function by analyses of Neuron Specific Enolase (NSE, µg/L) and (S100-β protein, pg/mL) and for determining inflammatory response by measuring Matrix Metallo-Proteinase-9 (MMP-9, ng/mL), and effect of these anesthetic drugs on oxidative stress by measuring Super Oxide Dismutase (SOD, U/L).
  8. Cognitive function scale: Mini-Mental State Examination (MMSE scale, if decreased more than 2 points from before operation indicate that the cognitive function of patients are declined) and pain index: Numerical Pain Rating scale (NPRS) (a scale from 0-10, where 0 = no pain and 10 = maximum worst pain) will be performed on all patients before, 1 hour, and 24 hours after operation.
  9. Heart rate (beat/min), oxygen saturation (%), and non-invasive blood pressure (mmHg) (systolic, diastolic, mean) will be recorded before and after operation.

10 Anesthesia duration (min) (the time from induction of anesthesia till stoppage of anesthesia) and operative duration (min) (the time from skin incision till skin closure) will be recorded.

  1. Time to emerge from anesthesia (min) (the time from stopping the use of anesthetics to patients relatively clearly answering the doctor's questions) will be recorded.
  2. The incidence of any perioperative adverse effects will be recorded as; tachycardia, bradycardia, hypertension, hypotension, nausea, vomiting, hypoxia, and bleeding.
  • Study design: This is a prospective, randomized (1:1), clinical trial, will be carried out on 44 patients who are candidate for elective, major, non-cardiac operations under general anesthesia.
  • Patients will be randomly allocated into two equal groups (22 patients each); group (P) for propofol and group (S) for sevoflurane.
  • The day before the operation, patients will be taught to measure postoperative pain based on the NPRS. Patients will be fasting for 6-8 h for a solid meal and 2 hours for clear fluid before the operation.
  • On arrival to the operating room, a peripheral IV cannula will be secured and standard monitoring using an electrocardiogram, pulse oximetry, and non-invasive blood pressure will be applied.
  • After preoxygenation with 100% oxygen for 3 min, general anesthesia will be induced using IV propofol (2 mg/kg) and IV fentanyl (1 μg/kg), and IV atracurium (0.5 mg/kg) will be given to facilitate tracheal intubation.
  • Lungs will be ventilated using volume-controlled ventilation and the tidal volume and ventilation rate will be adjusted to maintain end-tidal carbon dioxide at 35-45 mmHg.
  • Anesthesia will be maintained with either total intravenous anesthesia (TIVA) with propofol 6 mg/kg/h in group P or sevoflurane 1.0-1.5 minimum alveolar concentration (MAC) in group S.
  • Continuous infusion of IV atracurium (0.3 mg/kg/h), and IV fentanyl (0.5 ug/kg/h) till the end of surgery.
  • Thirty minutes before the end of the surgery all patients will be given IV paracetamol (15 mg/kg) for postoperative pain management.
  • At the end of the surgery, either TIVA pump or the inhalational anesthetic vaporizer will be turned off and the muscle relaxant will be reversed by giving IV neostigmine (0.04 mg/kg) plus IV atropine (0.02 mg/kg).
  • The patient will be extubated and transferred to the post-anesthesia care unit.
  • All data and study outcomes will be recorded by a researcher who is blinded to group assignment.
  • The primary outcome is the measure postoperative cognitive function by NSE.
Conditions
Anesthesia
Being tested
Propofol, Sevoflurane
Keywords
Postoperative Effects., Propofol, Sevoflurane, Anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PropofolDrug

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

  • SevofluraneDrug

    Also called Sevoflurane inhalant product

    Sevoflurane 1.0-1.5 minimum alveolar concentration (MAC)

Study groups in NCT05289349
Study groupRoleWhat they receive
group (P) for propofolActive comparatorpropofol 6 mg/kg/h in group P
Receives: Drug: Propofol
group (S) for sevoflurane.Active comparatorsevoflurane 1.0-1.5 minimum alveolar concentration (MAC) in group S.
Receives: Drug: Sevoflurane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neuron Specific Enolase (NSE, µg/L)

    Venous blood Level

    Measured: 1 hour after operation

  2. S100-β protein, pg/mL

    Venous blood Level

    Measured: 1 hour after operation

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

    Venous blood Level

    Measured: 1 hour after operation

  4. Super Oxide Dismutase (SOD, U/L)

    Venous blood Level

    Measured: 1 hour after operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2022
  2. Study start1 Dec 2021
  3. Primary completion31 Mar 2023
  4. Study completion1 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
prospective, randomized (1:1), double blind clinical trial
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05289349
Sponsor's protocol ID
Propofol/Sevofluran Anesthesia
Status last verified
Jun 2024
First submitted
13 Mar 2022
Last updated
4 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18394490
  • 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.

    PubMed 29243798
  • 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.

    PubMed 29563982

Questions about this trial

What is this clinical trial studying?

A study testing Propofol and Sevoflurane in people with Anesthesia, run by Rehab Werida at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neuron Specific Enolase (NSE, µg/L) (time frame: 1 hour after operation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05289349, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.

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