CompletedPhase 4ACTRN12625000175471

Effect of Adding Remifentanil to Thiopental Anaesthesia Induction on Classic Laryngeal Mask Airway Insertion Success: A Randomized Double-Blind Clinical Trial

Effect of Adding Remifentanil to Thiopental Anaesthesia Induction on Classic Laryngeal Mask Airway Insertion Success in ASA I-II Patients Undergoing Elective Surgery: A Randomized Double-Blind Clinical Trial


Sponsor

Firat University School of Medicine Hospital

Enrollment

120 participants

Start Date

Oct 15, 2013

Study Type

Interventional

Conditions

Summary

Remifentanil is a fast-acting medication often used in anesthesia to help patients stay comfortable during surgery. This study investigates whether combining remifentanil with thiopental, another anesthetic, improves the conditions for inserting a breathing device called a laryngeal mask airway (LMA). We aim to determine the best dose of remifentanil to achieve this without causing longer breathing interruptions.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria1

  • The study included 100 patients in class I-II according to ASA physical status classification, aged 18-65 years, undergoing elective surgery, without requiring muscle relaxant, with operation duration not exceeding 2 hours and with indications for LMA insertion.

Exclusion Criteria1

  • Patients with any neck or upper respiratory tract pathology, gastric content regurgitation-aspiration risk,history or probability of difficult airway (Mallampati class 3-4, sternomental distance less than 12 cm, thyromental distance less than 6 cm, head extension less than 90 degrees, mouth opening less than 1.5 cm), who were morbidly obese, had history of pulmonary disease, allergy to the study medications, history of alcohol and substance abuse, history of chronic sedative and opioid analgesic use, adrenocortical insufficiency, sore throat, dysphagia and dysphonia were not included in the study.

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Interventions

This study received approval from the Okmeydani Education and Research Pharmaceutical Research Local Ethics Committee (decision number 110), and informed consent was obtained from all patients. Conduc

This study received approval from the Okmeydani Education and Research Pharmaceutical Research Local Ethics Committee (decision number 110), and informed consent was obtained from all patients. Conducted from October 2013 to December 2013, the study included 100 ASA class I-II patients, aged 18-65 years, undergoing elective surgery without muscle relaxants, with operations lasting no more than 2 hours, and requiring LMA insertion. Patients with conditions such as neck or upper respiratory tract pathologies, high aspiration risk, morbid obesity, or difficult airway indicators (e.g., Mallampati class 3-4, limited neck mobility), along with those with histories of pulmonary disease, allergies to study medications, or substance dependence, were excluded. Standard monitoring included ECG (lead II), non-invasive blood pressure (SAP, DAP, MAP), SpO2, respiratory rate, end-tidal CO2, and inspired oxygen concentration. Anaesthesia depth was measured using a bispectral index (BIS-Vista™, Aspect Medical Systems, Newton, MA, USA). Patients received preoxygenation with 6 L/min oxygen, followed by IV midazolam (0.03 mg/kg). Patients were randomly assigned to four groups (n=25 per group) receiving 0.5, 1, 2, or 3 µg/kg remifentanil via coded syringes prepared by an independent anaesthesiologist. Remifentanil was infused over 60 seconds with an infusion pump (Braun Infusomat®). Thirty seconds after starting remifentanil, thiopental (5 mg/kg) was administered over 30 seconds. LMA was inserted 90 seconds after thiopental administration, provided BIS values were below 40 and adequate jaw relaxation was achieved. The conditions for LMA insertion were assessed using a 6-variable scale evaluating chin opening, ease of insertion, swallowing, coughing, laryngospasm, and patient movement. Outcomes were categorized as excellent, satisfactory, or poor. Hemodynamic parameters (SAP, DAP, MAP, HR, BIS, SpO2) were recorded at baseline, 1 minute before LMA insertion, and at 1, 2, 3, 4, and 5 minutes after insertion. Postoperative assessments included the presence of blood after LMA removal and evaluations for throat pain and dysphagia upon discharge from the recovery unit. Throat pain was scored from 0 (no complaints) to 3 (severe pain). Dysphagia was assessed as difficulty swallowing provoked by drinking.


Locations(2)

Turkey

Turkey

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