Etco2 Levels on the End-tidal Concentration of Sevoflurane

NCT ID: NCT05778968

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2024-07-29

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

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.

Conditions

End-tidal Sevoflurane; End-tidal Carbon Dioxide; Minimum Alveolar Concentration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

low ETCO2

Group Type: ACTIVE_COMPARATOR

low etco2

Intervention Type: PROCEDURE

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

normal ETCO2

Group Type: ACTIVE_COMPARATOR

normal etco2

Intervention Type: PROCEDURE

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

high ETCO2

Group Type: ACTIVE_COMPARATOR

high etco2

Intervention Type: PROCEDURE

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

Interventions

low etco2

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

Intervention Type: PROCEDURE

normal etco2

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

Intervention Type: PROCEDURE

high etco2

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

tarek abdel hay mostafa

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

thanaa elnomany, MD

Role: STUDY_DIRECTOR

tanta university, faculty of medicine

Locations

tarek Abdelhay Mostafa

Tanta, El Gharbyia, Egypt

Countries

Egypt

Other Identifiers

MAC of sevoflurane

Identifier Type: -

Identifier Source: org_study_id