AzTrials
AzTrials

Laparoscopic CholecystectomyNCT07440758

Low-Flow Sevoflurane and Desflurane Anesthesia in Laparoscopic Cholecystectomy

A study testing Sevoflurane and Desflurane in people with Laparoscopic Cholecystectomy and Postoperative Sore Throat, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Sevoflurane and Desflurane
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Mar 2026to 30 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kayseri City Hospital

    Kayseri, Kocasinan, 38080

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Low-Flow Sevoflurane and Low-Flow Desflurane Anesthesia on Postoperative Sore Throat in Laparoscopic Cholecystectomy Surgery

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.

Read more

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.

Read the detailed description

Postoperative sore throat (POST) is a common complaint occurring after extubation, with a reported incidence of 14-62%, and is primarily caused by mucosal irritation or injury related to orotracheal intubation and airway manipulation. Cough and hoarseness are also frequently observed complications following tracheal intubation and may negatively affect patient comfort; the incidence of these symptoms has been reported in the literature to range widely from 7% to 90%. Female sex, inappropriate endotracheal tube size, high cuff pressure, airway management devices, and the anesthetic and neuromuscular blocking agents used are among the factors associated with POST.

Low-flow anesthesia offers several advantages, including reduced heat and humidity loss, preservation of mucociliary activity, and decreased environmental pollution and cost. However, it requires close monitoring due to potential risks such as hypoxemia, hypercapnia, and hemodynamic or anesthetic depth alterations related to insufficient or excessive anesthetic delivery. Although some studies have suggested that desflurane, due to its irritant properties, may have more adverse effects on sore throat and cough compared with sevoflurane, the number of studies comparing these two agents under low-flow anesthesia conditions remains limited.

In this study, cuff pressure was standardized within the range of 20-30 cmH₂O and endotracheal tube sizes were determined according to sex in order to minimize potential confounding effects related to tube size and cuff pressure.

The study will be conducted at Kayseri City Hospital to compare low-flow sevoflurane and low-flow desflurane anesthesia in patients aged 18-65 years, classified as ASA physical status I-II, who are scheduled for elective laparoscopic cholecystectomy under general anesthesia.

All patients will receive standard monitoring including electrocardiography (ECG), non-invasive blood pressure, peripheral oxygen saturation (SpO₂), and capnography. Depth of anesthesia will be monitored using the Bispectral Index (BIS), and neuromuscular blockade will be assessed with Train-of-Four (TOF) monitoring. Prior to induction, an anesthesia machine leak test will be performed and the CO₂ absorbent will be checked. A 20G intravenous line will be established and fluid infusion initiated. Induction will be achieved with fentanyl, lidocaine, propofol, and rocuronium. Orotracheal intubation will be performed using a Macintosh laryngoscope; cuffed endotracheal tubes with an internal diameter of 7.0-7.5 mm for females and 7.5-8.0 mm for males will be used. Cuff pressure will be maintained between 20-30 cmH₂O using a manometer.

During maintenance, remifentanil infusion will be administered. The concentration of the inhalational anesthetic agent and opioid dosage will be titrated to maintain a BIS value between 40-60 and mean arterial pressure within ±20% of baseline values. In both groups, a fresh gas flow of 4 L/min will be applied for the first 10 minutes, after which the flow will be reduced to 1 L/min to maintain low-flow anesthesia. Sevoflurane or desflurane concentrations will be adjusted according to age-related minimum alveolar concentration (MAC) values. Expiratory fraction of oxygen will be maintained above 50%, and 5 cmH₂O positive end-expiratory pressure (PEEP) will be applied. Pneumoperitoneum will be maintained at 10-14 mmHg, and patients will be positioned in reverse Trendelenburg position.

For postoperative analgesia, paracetamol and tramadol will be administered, and granisetron and dexamethasone will be given for postoperative nausea and vomiting (PONV) prophylaxis. Metoclopramide will be used as rescue antiemetic if necessary. Before extubation, oropharyngeal secretions will be carefully aspirated. Neuromuscular blockade will be reversed with neostigmine and atropine, and extubation will be performed once the TOF ratio exceeds 90% with adequate spontaneous respiration.

The primary outcome will be the presence and severity of postoperative sore throat assessed at 0, 2, 4, and 24 hours after extubation using a 4-point scale (0-3).

Secondary outcomes will include the presence and severity of postoperative hoarseness and cough at the same time intervals, the incidence and severity of postoperative nausea and vomiting, the requirement for rescue antiemetic, intraoperative consumption of inhalational anesthetic agents, duration of surgery and anesthesia, and patient satisfaction at 24 hours postoperatively.

Being tested
Sevoflurane, Desflurane
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
Medical subject headings
Postoperative Complications, Postoperative Nausea and Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SevofluraneDrug

    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.

  • DesfluraneDrug

    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.

Study groups in NCT07440758
Study groupRoleWhat they receive
Low-Flow Sevoflurane GroupActive comparatorIn 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).
Receives: Drug: Sevoflurane
Low-Flow Desflurane GroupActive comparatorIn 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).
Receives: Drug: Desflurane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence of Postoperative Sore Throat

    Presence (yes/no) at predefined postoperative time points.

    Measured: 0, 2, 4, and 24 hours postoperatively

Secondary outcomes (7)
  1. Severity of Postoperative Sore Throat

    Severity of postoperative sore throat assessed using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) at predefined postoperative time points.

    Measured: 0, 2, 4, and 24 hours postoperatively

  2. Postoperative hoarseness

    Presence (yes/no) and severity of postoperative hoarseness assessed using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe).

    Measured: 0, 2, 4, and 24 hours postoperatively

  3. Postoperative Cough

    Presence and severity of postoperative cough assessed using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe).

    Measured: 0, 2, 4, and 24 hours postoperatively

  4. Postoperative Dysphagia (Difficulty Swallowing)

    Presence of foreign body sensation in the throat will be assessed as a dichotomous variable (Yes/No).

    Measured: 0, 2, 4, and 24 hours postoperatively

  5. 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.

    Measured: At postoperative 0, 2, 4, and 24 hours

  6. Intraoperative Consumption of Inhalational Anesthetic Agents

    Total intraoperative consumption of inhalational anesthetic agents (sevoflurane or desflurane) measured during surgery.

    Measured: Intraoperative period

  7. Patient Satisfaction (5-Point Likert Scale)

    Patient satisfaction will be assessed using a 5-point Likert scale consisting of the following response options: 1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, and 5 = very satisfied.

    Measured: 24. hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2026
  2. Study start20 Mar 2026
  3. Primary completion1 Jul 2026
  4. Study completion30 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07440758
Sponsor's protocol ID
KSH-ANES-LFST-2026
Status last verified
Feb 2026
First submitted
23 Feb 2026
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Sevoflurane and Desflurane in people with Laparoscopic Cholecystectomy and Postoperative Sore Throat, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of Postoperative Sore Throat (time frame: 0, 2, 4, and 24 hours postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in