Etco2 Levels on the End-tidal Concentration of Sevoflurane

April 30, 2024 updated by: tarek abdel hay mostafa, Tanta University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • El Gharbyia
      • Tanta, El Gharbyia, Egypt, 31111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
end tidal concentration of sevoflurane
Time Frame: Total time of operation
end tidal concentration of sevoflurane is measured by multiple gas analyser during operation
Total time of operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

March 8, 2023

First Submitted That Met QC Criteria

March 20, 2023

First Posted (Actual)

March 22, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • MAC of sevoflurane

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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