None listed
Conditions
Brief summary
Sedation and analgesia during GI endoscopy under proceduralist guided sedation is limited by the dose dependent adverse effect profile of midazolam and fentanyl. Quality of sedation and patient comfort must be balanced against adverse effects such as respiratory depression, airway obstruction, and loss of verbal response. Intravenous lignocaine possesses a different side effect profile, with less sedative and respiratory effects. The airway reflex suppressive and analgesic properties of intravenous lignocaine may allow a reduction in the required dose of fentanyl and/or midazolam, limiting the incidence of clinically relevant adverse events (multimodal sedation) and allowing an improved quality of sedation. Intravenous lignocaine has shown to provide significant postoperative analgesia in open and laparoscopic abdominal surgery, with improved pain, reduced opioid requirements and improved quality of recovery. It has also been shown to improve tolerability of instrumentation of the upper airway, with improved haemodynamic following laryngoscopy and intubation, as well as decreased rates of coughing, gagging and laryngospasm with LMA insertion. The objective of this trial is to assess whether the addition of intravenous lignocaine as to standard sedation protocol reduces midazolam/fentanyl requirements, improves the quality of sedation and decreases adverse events in patients undergoing GI endoscopy. The trial will be a randomised, double-blind, placebo controlled trial. Patients will be stratified into those undergoing upper GI endoscopy, colonoscopy or both. Patients will be randomised to a loading bolus of 2mg/kg lignocaine or saline, at commencement of sedation, with further 0.5mg/kg lignocaine or saline boluses ever 15 mins for the duration of the procedure. Primary outcome will be midazolam/fentanyl dose. Secondary outcomes will be proceduralist rated quality of sedation, patient satisfaction with sedation, incidence of bradycardia, hypotension, desaturations, airway support and sedation failure.
Interventions
Patients will be randomised to an intravenous lignocaine (2%) or placebo (0.9% NaCl). Study drug will be administered as a bolus of 0.1ml/kg (2mg/kg lignocaine) by the anaesthetic researcher following initial dose of midazolam and fentanyl. Further boluses of 0.025ml/kg (0.5mg/kg lignocaine) will be given every 15mins for the duration of the procedure (approx 20 - 60 mins). The anaesthetic researcher will not be otherwise involved with the care of the patient. Midazolam and fentanyl will be titr
Patients will be randomised to an intravenous lignocaine (2%) or placebo (0.9% NaCl). Study drug will be administered as a bolus of 0.1ml/kg (2mg/kg lignocaine) by the anaesthetic researcher following initial dose of midazolam and fentanyl. Further boluses of 0.025ml/kg (0.5mg/kg lignocaine) will be given every 15mins for the duration of the procedure (approx 20 - 60 mins). The anaesthetic researcher will not be otherwise involved with the care of the patient. Midazolam and fentanyl will be titrated to effect by the gastroenterologist (blinded to study drug) throughout the procedure according to their normal practice. They will be instructed to reduce their initial dose to 50% of what they would normally give to allow for potential reduced requirements, and titrate further sedation as needed.
Sponsors
Daniel Ellyard
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 80 Years
Healthy volunteers
No
Inclusion criteria
Elective (Outpatient) GI endoscopy (diagnostic or therapeutic) under proceduralist sedation (midazolam/fentanyl)
Exclusion criteria
- Pregnancy - History of significant cardiac arrhythmia or conduction delay or pacemaker - Pre-procedure bradycardia (HR<50) - Cardiac failure equivalent to NYHA III/IV - COPD requiring home O2, or saturations <94% on room air - Chronic Liver Disease/Cirrhosis - Chronic Renal Failure - History of epilepsy or seizure disorder - Recent administration of fluvoxamine, verapamil or ciprofloxacin - Cognitive impairment significant enough to preclude informed consent - Insufficient English to enable informed consent
Outcome results
None listed