Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:05 PM
Study NCT ID:
NCT07440758
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-Flow Sevoflurane and Desflurane Anesthesia in Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D000077335', 'term': 'Desflurane'}], 'ancestors': [{'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D005019', 'term': 'Ethyl Ethers'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence and Severity of Postoperative Sore Throat', 'timeFrame': '0, 2, 4, and 24 hours postoperatively', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Postoperative hoarseness', 'timeFrame': '0, 2, 4, and 24 hours postoperatively', 'description': 'Presence (yes/no) and severity of postoperative hoarseness assessed using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe).'}, {'measure': 'Postoperative Cough', 'timeFrame': '0, 2, 4, and 24 hours postoperatively', 'description': 'Presence and severity of postoperative cough assessed using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe).'}, {'measure': 'Postoperative Foreign Body Sensation in the Throat', 'timeFrame': '0, 2, 4, and 24 hours postoperatively', 'description': 'Presence of foreign body sensation in the throat will be assessed as a dichotomous variable (Yes/No).'}, {'measure': 'Presence and Severity of Postoperative Nausea and Vomiting (PONV)', 'timeFrame': 'At postoperative 0, 2, 4, and 24 hours', 'description': '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.'}, {'measure': 'Intraoperative Consumption of Inhalational Anesthetic Agents', 'timeFrame': 'Intraoperative period', 'description': 'Total intraoperative consumption of inhalational anesthetic agents (sevoflurane or desflurane) measured during surgery.'}, {'measure': 'Patient Satisfaction (5-Point Likert Scale)', 'timeFrame': '24. hours postoperatively', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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'], 'conditions': ['Laparoscopic Cholecystectomy', 'Postoperative Sore Throat']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.\n\nThe 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.\n\nThe 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.', 'detailedDescription': '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.\n\nLow-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.\n\nIn 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.\n\nThe 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.\n\nAll 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.\n\nDuring 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.\n\nFor 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.\n\nThe 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).\n\nSecondary 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status I-II\n* Aged between 18 and 65 years\n* Patients who provide written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Patients with a recent history of upper respiratory tract infection\n* Patients with a recent history of sore throat\n* Patients with chronic cough\n* Patients with a history of previous neck or tracheal surgery\n* Patients with predictors of difficult intubation\n* Patients with a history of difficult intubation\n* Obese patients (BMI \\> 35 kg/m²)\n* Patients with chronic respiratory diseases (asthma, COPD)\n* Pregnancy\n* Use of dexamethasone\n* Patients with hepatic impairment\n* Patients with allergy to paracetamol, tramadol, granisetron, dexamethasone, or metoclopramide\n* Patients with known allergy to halogenated anesthetic agents\n* Patients with a history of malignant hyperthermia\n* Patients with mental disorders or those unable to provide reliable assessment'}, 'identificationModule': {'nctId': 'NCT07440758', 'briefTitle': 'Low-Flow Sevoflurane and Desflurane Anesthesia in Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kayseri City Hospital'}, 'officialTitle': 'The Effect of Low-Flow Sevoflurane and Low-Flow Desflurane Anesthesia on Postoperative Sore Throat in Laparoscopic Cholecystectomy Surgery', 'orgStudyIdInfo': {'id': 'KSH-ANES-LFST-2026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Low-Flow Sevoflurane Group', 'description': '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).', 'interventionNames': ['Drug: Sevoflurane']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low-Flow Desflurane Group', 'description': '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.\n\nThe 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).', 'interventionNames': ['Drug: Desflurane']}], 'interventions': [{'name': 'Sevoflurane', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Low-Flow Sevoflurane Group']}, {'name': 'Desflurane', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Low-Flow Desflurane Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38080', 'city': 'Kayseri', 'state': 'Kocasinan', 'country': 'Turkey (Türkiye)', 'facility': 'Kayseri City Hospital', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}], 'centralContacts': [{'name': 'Emine Sümeyye Akköze', 'role': 'CONTACT', 'email': 'smyyclk51@gmail.com', 'phone': '+903523157700', 'phoneExt': '+905342113708'}, {'name': 'Şaziye Burcu Tufaoğulları Erdoğan', 'role': 'CONTACT', 'email': 'burcutuf@yahoo.com', 'phone': '+903523157700', 'phoneExt': '+905062734602'}], 'overallOfficials': [{'name': 'Şaziye Burcu Tufanoğulları Erdoğan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kayseri City Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kayseri City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant Doctor', 'investigatorFullName': 'Emine Sümeyye Akköze', 'investigatorAffiliation': 'Kayseri City Hospital'}}}}