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.
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
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
- Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University.
- Ethical committee approval will be obtained from Ethics committee of General Organization for Teaching Hospitals and Institutes.
- 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.
- All participants should agree to take part in this clinical study and will provide informed consent.
- Demographic data; age (year), sex (female/male), weight (kg), height (cm), BMI (kg/m2) will be collected.
- ASA physical status will be recorded.
- 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).
- 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.
- 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.
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| group (P) for propofol | Active comparator | propofol 6 mg/kg/h in group P Receives: Drug: Propofol |
| group (S) for sevoflurane. | Active comparator | sevoflurane 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.
Neuron Specific Enolase (NSE, µg/L)
Venous blood Level
Measured: 1 hour after operation
S100-β protein, pg/mL
Venous blood Level
Measured: 1 hour after operation
Matrix Metallo-Proteinase-9 (MMP-9, ng/mL)
Venous blood Level
Measured: 1 hour after operation
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.
- First posted21 Mar 2022
- Study start1 Dec 2021
- Primary completion31 Mar 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Rehab Werida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rehab Werida, Damanhour University
- Investigators
- Rehab H Werida, Ass Prof., Study chair, Damanhour UniversityAmira Kassem, Ph.D, Principal investigator, Damanhour UniversityAhmed Shaat, Ph.D., Principal investigator, Damanhour Teaching HospitalHeba Elwan, Principal investigator, Damanhour UniversityAhmad Salahuddin, Ph.D, Principal investigator, Damanhour University
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 18394490Tian 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 29243798Zhao 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Effects of Propofol or Sevoflurane Anesthesia in Egyptian Patients
- ClinicalTrials.gov ID
- NCT05289349
- Acronym / sponsor ID
- Propofol/Sevofluran Anesthesia
- Conditions
- Anesthesia
- Keywords
- Postoperative Effects., Propofol, Sevoflurane, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Rehab WeridaUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University.
- Ethical committee approval will be obtained from Ethics committee of General Organization for Teaching Hospitals and Institutes.
- 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.
- All participants should agree to take part in this clinical study and will provide informed consent.
- Demographic data; age (year), sex (female/male), weight (kg), height (cm), BMI (kg/m2) will be collected.
- ASA physical status will be recorded.
- 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).
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, randomized (1:1), double blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| group (P) for propofol | Active comparator | Drug: Propofolpropofol 6 mg/kg/h in group P |
| group (S) for sevoflurane. | Active comparator | Drug: Sevofluranesevoflurane 1.0-1.5 minimum alveolar concentration (MAC) in group S. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolPropofol (2 mg/kg) for induction of anesthesia , and ( 6 mg/kg/h) for maintenance of anesthesia | Drug | group (P) for propofol |
| SevofluraneAlso: Sevoflurane inhalant productSevoflurane 1.0-1.5 minimum alveolar concentration (MAC) | Drug | group (S) for sevoflurane. |
Primary outcome
Neuron Specific Enolase (NSE, µg/L)
Time frame: 1 hour after operation
Venous blood Level
S100-β protein, pg/mL
Time frame: 1 hour after operation
Venous blood Level
Matrix Metallo-Proteinase-9 (MMP-9, ng/mL)
Time frame: 1 hour after operation
Venous blood Level
Super Oxide Dismutase (SOD, U/L)
Time frame: 1 hour after operation
Venous blood Level
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Background: PubMed 18394490Caza 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.
- Background: PubMed 29243798Tian 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.
- Background: PubMed 29563982Zhao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rehab H Werida, Ass Prof. study chair
Damanhour University
Amira Kassem, Ph.D principal investigator
Damanhour University
Ahmed Shaat, Ph.D. principal investigator
Damanhour Teaching Hospital
1 site in 1 country: see every site and its status.
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.