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Comparison Of The Effects Of Propofol-Dexmedetomidine And Thiopental-Dexmedetomidine Combinations On The Success Of Classical Laryngeal Mask Airway Insertion

Comparison Of The Effects Of Propofol-Dexmedetomidine And Thiopental-Dexmedetomidine Combinations On The Success Of Classical Laryngeal Mask Airway Insertion, Hemodynamic Response And Pharyngolaryngeal Morbidity in participants undergoing elective surgery.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000061437
Enrollment
80
Registered
2025-01-21
Start date
2013-10-01
Completion date
2014-04-01
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Dexmedetomidine is a potent selective a2 receptor agonist with analgesic and sedative effects. Many reports indicate that the combination of dexmedetomidine with propofol provides comparably acceptable conditions for laryngeal mask airway (LMA). However, no study has evaluated the effectiveness of combined dexmedetomidine and thiopental in LMA insertion compared to that of combined dexmedetomidine and propofol. This prospective, randomized, double-blind study aimed to compare the effects of dexmedetomidine with thiopental or propofol on LMA insertion conditions, hemodynamic response and pharyngolaryngeal morbidity. The study showed that the use of dexmedetomidine with thiopental provided comparably acceptable LMA insertion conditions with more stable hemodynamics compared to propofol.

Interventions

A total of 80 patients aged 18–65 years with ASA I-II physical status undergoing elective surgery with LMA insertion were included. Muscle relaxants were not used, and surgeries were limited to less than 2 hours. Patients with neck or upper respiratory pathologies, difficult airway history, morbid obesity, lung disease, or chronic sedative/opioid use were excluded. All patients underwent standard monitoring (HR, SAP, DAP, MAP, ECG, and SpO2) prior to anesthesia induction. Anesthesia depth was m

A total of 80 patients aged 18–65 years with ASA I-II physical status undergoing elective surgery with LMA insertion were included. Muscle relaxants were not used, and surgeries were limited to less than 2 hours. Patients with neck or upper respiratory pathologies, difficult airway history, morbid obesity, lung disease, or chronic sedative/opioid use were excluded. All patients underwent standard monitoring (HR, SAP, DAP, MAP, ECG, and SpO2) prior to anesthesia induction. Anesthesia depth was measured using bispectral index (BIS) monitoring. A 20G IV cannula was inserted, and 7 mL·kg saline infusion was administered. Group P (Control Group): 2 µg/kg remifentanil followed by 2.5 mg/kg propofol. Group T (Intervention Group): 2 µg/kg remifentanil followed by 5 mg/kg thiopental. After induction, the LMA was inserted 90 seconds later when BIS was <40 and jaw relaxation was sufficient. Placement was performed by a single, experienced researcher using the standard technique, and cuff pressure was maintained at 60 cmH2O. Assessment of LMA Insertion: Conditions for LMA insertion were evaluated during the first attempt only using a 6-variable scale (jaw opening, ease of insertion, swallowing, coughing, laryngospasm, and movement). Insertion conditions were rated as: Optimal: All criteria were excellent. Acceptable: A mix of excellent and good criteria. Poor: At least one poor criterion. Monitoring Adherence to the Intervention: Drug preparation and administration were conducted using blinded syringes. A researcher independent of the anesthesia process monitored LMA placement conditions and patient responses. Adherence was ensured through detailed documentation of drug dosages, LMA attempts, and peroperative parameters. Perioperative and Postoperative Outcomes: SAP, DAP, MAP, HR, BIS, and SpO2 were recorded 1 minute before and at 1, 2, 3, 4, and 5 minutes after LMA insertion. Apnea duration, defined as the time from the last spontaneous breath after induction to the first spontaneous breath, was recorded. Postoperatively, patients were evaluated for: Sore Throat: Rated on a 0–3 scale (none, mild, moderate, severe). Dysphagia: Presence or absence determined by difficulty swallowing water. Blood Presence on LMA: Graded as none, trace, or significant. Hypotension (MAP <30% below baseline) was treated with 6 mg of ephedrine, and bradycardia (HR <50 bpm) was treated with 0.5 mg IV atropine.

Sponsors

Firat University Faculty of Medicine
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

A total of 80 patients who were between the ages of 18 and 65 years, were in class I-II according to the American Society of Anesthesiologists (ASA) physical status classification system, were undergoing elective surgery not exceeding 2 hours in duration, did not require muscle relaxant, and had indication for LMA insertion were included in the study.

Exclusion criteria

Patients with any of the following were excluded: neck or upper respiratory tract pathology, sore throat, dysphagia, or dysphonia; history or risk factors for 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); morbid obesity; or history of lung disease, alcohol or substance addiction, chronic sedative or opioid analgesic use, or allergy to the study drugs.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026