Low-Flow Sevoflurane and Desflurane Anesthesia in Laparoscopic Cholecystectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKayseri City Hospital
About this trial
Several studies have demonstrated that inhalational anesthetic agents such as desflurane and sevoflurane may cause varying degrees of postoperative sore throat, hoarseness, and cough in orotracheally intubated patients. However, data evaluating these outcomes under low-flow anesthesia conditions remain limited and insufficient.
This single-center, prospective, randomized controlled study will be conducted in patients aged 18-65 years, classified as American Society of Anesthesiologists (ASA) physical status I-II, who are scheduled to undergo elective laparoscopic cholecystectomy under general anesthesia and who provide written informed consent to participate in the study.
The primary objective of the study is to compare the effects of low-flow desflurane and low-flow sevoflurane anesthesia on the incidence and severity of postoperative sore throat.
The secondary outcomes include the evaluation of postoperative hoarseness and cough, the incidence of postoperative nausea and vomiting (PONV), and the total consumption of inhalational anesthetic agents.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
American Society of Anesthesiologists (ASA) physical status I-II
Aged between 18 and 65 years
Patients who provide written informed consent to participate in the study
Disqualifiers
Patients with a recent history of upper respiratory tract infection
Patients with a recent history of sore throat
Patients with chronic cough
Patients with a history of previous neck or tracheal surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Sevoflurane
DrugSevoflurane was used for maintenance of general anesthesia under low-flow conditions (fresh gas flow ≤1 L/min) during laparoscopic cholecystectomy. Anesthetic depth was adjusted according to standard monitoring and MAC values. The agent will administered until the end of surgery.
Desflurane
DrugDesflurane was used for maintenance of general anesthesia under low-flow conditions (fresh gas flow ≤1 L/min) during laparoscopic cholecystectomy. Anesthetic depth was adjusted according to standard monitoring and MAC values. The agent will administered until the end of surgery.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Low-Flow Sevoflurane GroupActive comparator 1 intervention
Group B: Low-Flow Desflurane GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Presence and Severity of Postoperative Sore Throat
Presence (yes/no) and severity of postoperative sore throat assessed using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) at predefined postoperative time points.
Time frame
0, 2, 4, and 24 hours postoperativelySecondary outcomes
1
Postoperative hoarseness
Presence (yes/no) and severity of postoperative hoarseness assessed using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe).
Time frame
0, 2, 4, and 24 hours postoperatively2
Postoperative Cough
Presence and severity of postoperative cough assessed using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe).
Time frame
0, 2, 4, and 24 hours postoperatively3
Postoperative Foreign Body Sensation in the Throat
Presence of foreign body sensation in the throat will be assessed as a dichotomous variable (Yes/No).
Time frame
0, 2, 4, and 24 hours postoperatively4
Presence and Severity of Postoperative Nausea and Vomiting (PONV)
Presence and severity of postoperative nausea and vomiting assessed using a standardized 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). The need for rescue antiemetic medication.
Time frame
At postoperative 0, 2, 4, and 24 hoursSponsors and contacts
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Source ClinicalTrials.gov