Anesthetist Controlled Versus Patient-controlled Sedation: Risks and Benefits, a Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Patient satisfaction assessed by 7 point Likert scale.
Study Overview
Brief Summary
Perioperative anxiety has many hazards and should be eliminated. Patients undergoing ophthalmologic procedures often undergo it under local anesthesia. In a trial to improve patients' satisfaction sedation is given. Sedation could be given either by an anesthetist or patient-controlled methods. This study compared both methods of sedation in terms of safety, depth of sedation, and patient satisfaction.
Detailed Description
This randomized controlled trial was conducted in Kasr Al Ainy Hospital, Ophthalmology surgeries operation theatre, Cairo University, Cairo, Egypt.
After the approval of the research ethical committee (approval number MD-18-2019) & obtaining written informed consent from every patient, 30 patients belonging to the American society of anesthesiologists (ASA) status I, II, aging from 40 to 65 years old, both genders, co-operative patients aware of the instructions, scheduled for cataract surgery under local anesthesia were enrolled for this randomized controlled trial.
However, patients with a diagnosis of cognitive impairment or mental disorder, hypersensitivity to any of the used drugs, having any conditions contraindicating local anesthesia (e.g. Coagulation disorders) were excluded from the study.
Furthermore, patients having severe pulmonary disease e.g. (obstructive sleep apnea), patients using sedative medications within the previous month, and patients with chronic renal and cardiac disorder (e.g. chronic renal failure, heart failure) were also excluded from the study.
Patients were randomly assigned into two equal groups of 15 patients each, the anesthetist controlled group Ga (n=15) and the patient-controlled group Gp (n=15). Randomization was done using computer-generated numbers and the allocation sequence of the participants was concealed in sequentially numbered sealed opaque envelopes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •ASA physical status I, II.
- •Age group 40-65 years old.
- •Co-operative patients aware of the instructions.
Exclusion Criteria
- •Diagnosis of cognitive impairment or mental disorder.
- •Hypersensitivity to any of the used drugs.
- •Contraindication to local anesthesia e.g. Coagulation disorder.
- •Severe pulmonary disease e.g. (obstructive sleep apnea).
- •Use of sedative medications within the previous month.
- •Chronic renal and cardiac disorder e.g. (chronic renal failure, heart failure).
Arms & Interventions
Anesthetist controlled group
15 patients undergoing cataract surgery will receive sedation given by the anesthetist together with local anesthesia according to the depth of sedation in the form of intravenous Midazolam and Fentanyl.
Intervention: Midazolam-Fentanyl combination (Drug)
Patient-controlled group
15 patients undergoing cataract surgery under local anesthesia will administer sedation to themselves through a pump.
Intervention: Midazolam-Fentanyl combination (Drug)
Outcomes
Primary Outcomes
Patient satisfaction assessed by 7 point Likert scale.
Time Frame: Intraoperative for 1 hour.
Assessed by 7 point Likert scale (ranging from 1 as minimum value and 7 as maximal value), higher value is better.
Secondary Outcomes
- Systolic and diastolic blood pressures.(Intraoperative for 1 hour.)
- Surgeons' satisfaction assessed by 7 point Likert scale.(Intraoperative for 1 hour.)
- Patient's anxiety assessed by State trait anxiety inventory.(Intraoperative for 1 hour.)
- Heart rate.(Intraoperative for 1 hour.)
- Respiratory rate.(Intraoperative for 1 hour.)
- Oxygen saturation.(Intraoperative for 1 hour.)
- Time to patient ambulation in minutes.(Postoperative for up to 1 hour.)
Investigators
Mohamed Ahmed Shamma
Assistant lecturer of anaesthesia, surgical ICU and pain management kasr al aini
Cairo University