Etco2 Levels on the End-tidal Concentration of Sevoflurane
The Effect of Different Etco2 Levels on the End-tidal Concentration of Sevoflurane in Patients Undergoing Laparoscopic Cholecystectomy
1 other identifier
interventional
90
1 country
1
Brief Summary
he assessment of adequate levels of anaesthesia traditionally relies not only on a patient's movement but also on the hemodynamic response (or both) to a surgical stimulus
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2023
CompletedFirst Submitted
Initial submission to the registry
March 8, 2023
CompletedFirst Posted
Study publicly available on registry
March 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 29, 2024
CompletedJuly 30, 2024
July 1, 2024
1.3 years
March 8, 2023
July 29, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
end tidal concentration of sevoflurane
end tidal concentration of sevoflurane is measured by multiple gas analyser during operation
Total time of operation
Study Arms (3)
low ETCO2
ACTIVE COMPARATORnormal ETCO2
ACTIVE COMPARATORhigh ETCO2
ACTIVE COMPARATORInterventions
Etco2 levels will be adjusted at levels ranging between 25 mm Hg and 30 mm Hg
Etco2 levels will be adjusted at levels ranging between 31 mm Hg and 40 mm Hg
Etco2 levels will be adjusted at levels ranging between 41 mm Hg and 45 mm Hg
Eligibility Criteria
You may qualify if:
- American Society of anaesthesiologist ASA physical status I, II
- admitted for laparoscopic cholecystectomy
You may not qualify if:
- Refusal of patients.
- Patients with renal or liver dysfunction.
- Patients with chronic pain other than cholelithiasis.
- Cardiac disorders as uncontrolled hypertension, arrhythmia, Ischaemic heart disease, valvular heart disease and pulmonary hypertension.
- Patient with haematological disorder as Sickle cell disease.
- Chest patient as asthma, COPD.
- Combined surgery .
- History of allergy to any of the study drugs.
- Patients with communication problems, cognitive dysfunction, or psychological disorders.
- Patients who received analgesics or sedatives 24 h before a scheduled surgery.
- Alcohol or drug abuse.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
tarek Abdelhay Mostafa
Tanta, El Gharbyia, 31111, Egypt
Study Officials
- STUDY DIRECTOR
thanaa elnomany, MD
tanta university, faculty of medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
March 8, 2023
First Posted
March 22, 2023
Study Start
February 1, 2023
Primary Completion
June 1, 2024
Study Completion
July 29, 2024
Last Updated
July 30, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share