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A randomized controlled trial on the safety and efficacy of dexmedetomidine compared to propofol among patients undergoing arthroscopic shoulder surgery under conscious sedation and regional anaesthesia in the beach chair position

Randomized clinical trial of the use of dexmedetomidine VS propofol for conscious sedation for arthroscopic shoulder surgery under interscalene block in beach chair position.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2021/036
Enrollment
Unknown
Registered
2021-12-17
Start date
2022-01-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Conscious sedation and regional anaesthesia for arthroscopic shoulder surgery in beach chair position

Interventions

Study setting The study will be set in the Teaching Hospital Anuradhapura, Sri Lanka. Surgical operations theatre. Randomization A computer-generated randomization list was created through Microsoft

Sponsors

Dr. Minura Hapugoda
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All consenting patients males and females, with the American Society Anaesthesiologist (ASA) physical status of I or II awaiting arthroscopic shoulder surgery under regional anaesthesia in beach chair position at Teaching Hospital Anuradhapura. Minimum age of patients is 18 years with a maximum of 80 years.

Exclusion criteria

Exclusion criteria: • Patients with significant coagulopathy: Patients with a platelet count of less than 100,000, an international normalizing ratio(INR) more than 1.5 and patients on anticoagulants such as warfarin, heparin and clopidogrel. • Infection at the injection site • Known allergy to local anaesthetics and sedatives (Propofol & Dexmedomidine) • Inability to cooperate during block placement or surgery • A body mass index more than 35 Kg/m2 • Pre-existing loss of force or sensation in the operative limb • Significant organ dysfunction (cardiac- patients with heart block, bradycardia, severe ventricular dysfunction, hypovolaemia, or chronic uncontrolled hypertension, pulmonary, renal, hepatic impairment and uncontrolled diabetes mellitus) • Failed interscalene block during the present intervention and converted to general anaesthesia.

Design outcomes

Primary

MeasureTime frame
Change in systolic blood pressure (SBP) and mean arterial pressure (MAP) [At baseline (on arrival at the operating room prior to block placement), then every 15 minutes until the end of propofol or dexmedetomidine infusion] Change in heart rate (HR) [At baseline (on arrival at the operating room prior to block placement), then every 15 minutes until the end of propofol or dexmedetomidine infusion] The need for airway interventions The need for chin lift, jaw thrust & head tilt, airway adjuncts such as nasopharyngeal airway, oropharyngeal airway to maintain the airway [When the patient cannot maintain the airway from the start of infusion of Propofol or Dexmedetomidine till the end where infusion is stopped.] Length of PACU stay [The time duration in minutes measured from the time the patient enters the Post Anaesthesia Care Unit (PACU) to discharge from the PACU following a modified Aldrete score of >9 . The time spent in the PACU is documented by nursing officer blinded to the sedation used] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [ ] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] []

Secondary

MeasureTime frame
Patient Satisfaction 1 (PS1) measures on [I would want to have the same anesthetic again on a 5 points Likert scale from 0 to 4: 0= Strongly disagree, 1= Disagree, 2= Neither agree nor disagree, 3= Agree, 4= Strongly agree [Measured at postoperative 24-hour period.] Patient Satisfaction 2 (PS2) [I was satisfied with my anaesthetic care on a 5 points Likert scale from 0 to 4: 0= Strongly disagree, 1= Disagree, 2= Neither agree nor disagree, 3= Agree, 4= Strongly agree [Measured at postoperative 24-hour period.] Patient Satisfaction 3(PS3) [I felt relaxed and no pain during the surgery on a 5 points Likert scale from 0 to 4: 0= Strongly disagree, 1= Disagree, 2= Neither agree nor disagree, 3= Agree, 4= Strongly agree. [Measured at postoperative 24-hour period.] Postoperative analgesia duration [The time duration measured from the time of successful nerve block onset to the first onset of pain postoperatively in minutes ] Postoperative opioid analgesic consumption [Measured from the end of surgery to 24 hours. The total amount in milligrams of prescribed opioids for the patient ] Complications of interscalene block. Ultrasound evidence of hemi-diaphragmatic paralysis [ultrasound appearance of paradoxical movement, through diaphragmatic excursion of less than 4 mm, and a difference >50% between the excursion of one hemidiaphragm compared to the othe [Measured at PACU postoperatively] Neurological complications [Patients are asked a standardized set of questions via telephone interview in relation to the operative limb; do you have any numbness? Do you have any tingling? Do you have any abnormal sensations? Do you have any pain? Do you have any weakness? If the patient complains of any neurological complications, then further queries are to be made taking into account the anatomy relevant to the surgery and the peripheral nerve/plexus block. Symptoms that are immediately adjacent to the wound, consistent with normal tissue healing or the initial trauma are not conside

Countries

Sri Lanka

Contacts

Public ContactDr. Minura Hapugoda

Medical Officer in Anaesthesia

minura1988@gmail.com0252224810

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026