Low-Flow Sevoflurane and Desflurane Anesthesia in Laparoscopic Cholecystectomy

NCT07440758 | Recruiting

• 1 other identifier: KSH-ANES-LFST-2026
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Laparoscopic Cholecystectomy; Postoperative Sore Throat

Keywords

Postoperative sore throat; Low-flow anesthesia; Sevoflurane; Desflurane; Laparoscopic cholecystectomy; General anesthesia; Orotracheal intubation; Endotracheal cuff pressure; Postoperative complications; Postoperative nausea and vomiting; PONV

Outcome Measures

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.

  0, 2, 4, and 24 hours postoperatively

Secondary Outcomes (6)

• Postoperative hoarseness

  0, 2, 4, and 24 hours postoperatively

• Postoperative Cough

  0, 2, 4, and 24 hours postoperatively

• Postoperative Foreign Body Sensation in the Throat

  0, 2, 4, and 24 hours postoperatively

• Presence and Severity of Postoperative Nausea and Vomiting (PONV)

  At postoperative 0, 2, 4, and 24 hours

• Intraoperative Consumption of Inhalational Anesthetic Agents

  Intraoperative period

Study Arms (2)

Low-Flow Sevoflurane Group

ACTIVE COMPARATOR

In the Low-Flow Sevoflurane Group (DS), a combination of 4 L/min fresh gas flow consisting of 50% O₂ and 50% air with 2-3% sevoflurane will be administered during the first 10 minutes. Thereafter, the fresh gas flow will be reduced to 1 L/min, and a mixture of 50% O₂ and 50% air with 3-4% sevoflurane will be administered. The concentration of the inhalational anesthetic agents and the rate of remifentanil infusion will be titrated by the attending anesthesiologists to maintain the Bispectral Index (BIS) between 40 and 60, to keep the mean arterial pressure within ±20% of baseline values, and to achieve the age-adjusted minimum alveolar concentration (MAC).

Drug: Sevoflurane

Low-Flow Desflurane Group

ACTIVE COMPARATOR

In the Low-Flow Desflurane Group (DD), a combination of 4 L/min fresh gas flow consisting of 50% O₂ and 50% air with 6% desflurane will be administered for the first 10 minutes. Thereafter, the fresh gas flow will be reduced to 1 L/min, and a mixture of 50% O₂ and 50% air with 7-8% desflurane will be administered. The concentration of the inhalational anesthetic agent and the rate of remifentanil infusion will be titrated by the attending anesthesiologists to maintain the Bispectral Index (BIS) between 40 and 60, to keep the mean arterial pressure within ±20% of baseline values, and to achieve the age-adjusted minimum alveolar concentration (MAC).

Drug: Desflurane

Interventions

Sevoflurane DRUG

Sevoflurane 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.

Low-Flow Sevoflurane Group

Desflurane DRUG

Desflurane 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.

Low-Flow Desflurane Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patients with predictors of difficult intubation
• Patients with a history of difficult intubation
• Obese patients (BMI \> 35 kg/m²)
• Patients with chronic respiratory diseases (asthma, COPD)
• Pregnancy
• Use of dexamethasone
• Patients with hepatic impairment
• Patients with allergy to paracetamol, tramadol, granisetron, dexamethasone, or metoclopramide
• Patients with known allergy to halogenated anesthetic agents
• Patients with a history of malignant hyperthermia
• Patients with mental disorders or those unable to provide reliable assessment

Sponsors & Collaborators

• Kayseri City Hospital: lead

Study Sites (1)

Kayseri City Hospital

Kayseri, Kocasinan, 38080, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Postoperative Complications; Postoperative Nausea and Vomiting

Interventions

Sevoflurane; Desflurane

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Ethyl Ethers

Study Officials

• Şaziye Burcu Tufanoğulları Erdoğan

  Kayseri City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emine Sümeyye Akköze

CONTACT

+903523157700; smyyclk51@gmail.com

Şaziye Burcu Tufaoğulları Erdoğan

CONTACT

+903523157700; burcutuf@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Doctor

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)