Etco2 Levels on the End-tidal Concentration of Sevoflurane

Sponsor

Tanta University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05778968

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

12.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
End-tidal Sevoflurane End-tidal Carbon Dioxide Minimum Alveolar Concentration	Procedure: low etco2 Procedure: normal etco2 Procedure: high etco2	N/A

Detailed Description

Currently a derivative of MAC namely, end tidal partial pressure (FET) displayed on the work station as concentration , maybe an alternative useful measure of the anaesthetic effect of an inhaled anaesthetic agent

. Many pharmacological factors have been associated with alterations in MAC and Mac derivatives such as nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics, and anesthetics.

However, few studies have focused on physiological factors, such as hypercarbia or hypocarbia. A correlation has been found between Paco2 and Etco2 in ventilated patients with healthy lungs. Some authors have suggested that Etco2 could be considered appropriate for estimating Paco2 even in critical patients. Knowledge of the effects of Paco2 on end tidal concentration of sevoflurane among patients undergoing laparoscopic cholecystectomy may help anaesthesiologists titrate sevoflurane carefully and precisely during different mechanical ventilation settings to avoid dose-dependent hypotension, impaired cardiac contractility, and hypothermia caused by excessive anaesthetic depth of sevoflurane.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

The Effect of Different Etco2 Levels on the End-tidal Concentration of Sevoflurane in Patients Undergoing Laparoscopic Cholecystectomy

Actual Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: low ETCO2	Procedure: low etco2 Etco2 levels will be adjusted at levels ranging between 25 mm Hg and 30 mm Hg
Active Comparator: normal ETCO2	Procedure: normal etco2 Etco2 levels will be adjusted at levels ranging between 31 mm Hg and 40 mm Hg
Active Comparator: high ETCO2	Procedure: high etco2 Etco2 levels will be adjusted at levels ranging between 41 mm Hg and 45 mm Hg

Arm

Intervention/Treatment

Active Comparator: low ETCO2

Procedure: low etco2

Etco2 levels will be adjusted at levels ranging between 25 mm Hg and 30 mm Hg

Active Comparator: normal ETCO2

Procedure: normal etco2

Etco2 levels will be adjusted at levels ranging between 31 mm Hg and 40 mm Hg

Active Comparator: high ETCO2

Procedure: high etco2

Etco2 levels will be adjusted at levels ranging between 41 mm Hg and 45 mm Hg

Outcome Measures

Primary Outcome Measures

end tidal concentration of sevoflurane [Total time of operation]
end tidal concentration of sevoflurane is measured by multiple gas analyser during operation

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

American Society of anaesthesiologist ASA physical status I, II
admitted for laparoscopic cholecystectomy

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	tarek Abdelhay Mostafa	Tanta	El Gharbyia	Egypt	31111

Sponsors and Collaborators

Tanta University

Investigators

Study Director: thanaa elnomany, MD, tanta university, faculty of medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

tarek abdel hay mostafa, principle investigator, Tanta University

ClinicalTrials.gov Identifier:

NCT05778968

Other Study ID Numbers:

MAC of sevoflurane

First Posted:

Mar 22, 2023

Last Update Posted:

Mar 22, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 22, 2023