PDF of Trial CTRI Website URL -

Transcription

1 Clinical Trial Details (PDF Generation Date :- Tue, 09 Oct :20:31 GMT) CTRI Number Last Modified On 23/07/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/09/ [Registered on: 03/09/2012] - Trial Registered Retrospectively Yes Interventional Drug Surgical/Anesthesia Randomized, Parallel Group Trial A clinical study to find whether dexmedetomidine provides adequate comfort to patients during awake nasal fibreoptic intubation Safety and Effectiveness of Dexmedetomidine for sedation during awake nasal fibreoptic intubation? A prospective, randomized, double blind study Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Designation Affiliation Details of Principal Investigator Anitha Shenoy Professor of Anaesthesiology Phone Fax Designation Affiliation department of Anaesthesia, Udupi anitharshenoy@yahoo.co.in Details Contact Person (Scientific Query) Anitha Shenoy Professor of Anaesthesiology department of Anaesthesia, Details Contact Person (Public Query) Phone Fax Designation Affiliation anitharshenoy@yahoo.co.in Details Contact Person (Public Query) Tajammul Sayeed Postgraduate in Anaesthesiology Phone Fax Department of Anaesthesia, Udupi page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria > Kasturba Hospital, Type of Sponsor List of Countries of Principal Investigator Umesh G tajammulsayeed@gmail.com Source of Monetary or Material Support Primary Sponsor Details Kasturba Hospital KMC Manipal Kasturba Hospital, Research institution and hospital of Site Site Phone/Fax/ Kasturba Hospital, Department of Anaesthesia, Kasturba Hospital, Udupi drumeshg@yahoo.co.in of Committee Approval Status Date of Approval Is Independent Ethics Committee? IEC, Kasturba Hospital, Status Not Applicable Health Type Patients Approved 14/09/2010 No Date No Date Specified Condition Scheduled for awake nasal fibreoptic intubation in view of assessed difficult airway Type Details Comparator Agent midazolam and fentanyl 1 mcg/kg fentanyl and 1 mg midazolam were administered as IV bolus just prior to fibrescopy Intervention dexmedetomidine 1 mcg/kg as bolus administered IV over 10 minutes prior to fibrescopy Age From Age To Gender Details Details Year(s) Year(s) Both Inclusion Criteria All patients between years undergoing awake nasal fibreoptic intubation Exclusion Criteria ASA physical status IV Raised intracranial pressure Uncontrolled seizure disorder and/or known psychiatric illness Current (in the past 14 days) treatment with an?2 agonist or antagonist Patients in whom dexmedetomidine or benzodiazepine administration is contra-indicated Patients with acute unstable angina, laboratory confirmed acute page 2 / 6

3 myocardial infarction within the past 6 weeks, heart rate Patients with elevated SGPT (ALT) and/or SGOT (AST) values of > 2 times the upper limit of normal. Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization An Open list of random numbers Participant, Investigator and Outcome Assessor Blinded Primary Outcome Outcome Timepoints safety and effectiveness of dexmedetomidine for Endoscopy time, intubation time and intubation sedation during awake nasal fiberoptic intubation score were done during and immediately following awake fibreoptic intubation Secondary Outcome Outcome Timepoints Target Sample Size adverse events Phase of Trial Phase 4 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Total Sample Size=36 Sample Size from =36 07/10/2010 No Date Specified Years=1 Months=6 Days=10 Not Applicable Completed Not yet considered for publication during intubation and 24 h after surgery Two drops of oxymetazoline will be administered in each nostril to each study subject on the morning of surgery and on arrival to premedication area. In the premedication area, an intravenous access will be established and an infusion of a crystalloid will be started. IV glycopyrrolate 0.2 mg would be administered after establishing monitoring (12 lead electrocardiogram, non-invasive blood pressure and SpO 2 ) and recording baseline vitals. Patients will also be asked to gargle with lidocaine viscous 2% (5 ml) and nostrils will be packed with gauze soaked in 2% lidocaine with 1:2,00,000 epinephrine (5 ml). After this, patient will be shifted to operating room. Monitoring will be continued in the operating room. Serial dilatation of the nostril that has best patency will be performed with increasing sizes of nasopharyngeal airways that are lubricated with page 3 / 6

4 lidocaine jelly. Fibreoptic scope of 3.5 mm insertion cord diameter (FI-10BS/10RBS Pentax corporation, Tokyo, Japan) will be used for the study. Tracheal tubes (Portex) of 7.0 and 6.5 size will mounted onto the fiberscope for men and women respectively. Immediately after the end of study drug infusion, observer 2 will perform awake fibreoptic intubation. Oxygen (4 L.min -1 ) will be connected to the injection port. Once the glottic structures are identified, 2 ml 2% lidocaine will be sprayed (through a three-way tap in the oxygen tubing) on to the vocal cords. About a minute later, the fibrescpe will be advanced into the trachea and later the tracheal tube will be advanced over the fibrescope. General anaesthesia will be induced, after confirming appropriate positioning of the tracheal tube with fibreoptic visualization and ETCO 2. Bradycardia (< 50 bpm) will be treated with IV inj Atropine (0.6 mg). Hypotension (Systolic blood pressure < 90 mmhg) will be treated with incremental doses of mephentermine. Our outcome measures will be a) Nasal Intubation Score 1: no movement 2: grimacing page 4 / 6

5 3: mild cough 4: major limb movement 5: prolonged cough b) Post-intubation Score 1: cooperative 2: restless, minimal resistance 3: severe resistance, (general anaesthesia) immediately c) Airway Obstruction Score (prior to intubation) 1: patent airway 2: airway obstruction relieved by neck extension 3: airway obstruction requiring jaw retraction d) Time to intubation: This will be measured from insertion of fiberscope into nostril till confirmation of nasal tracheal intubation by fibreoptic visualization of tracheal tube in the trachea. page 5 / 6

6 Powered by TCPDF ( PDF of Trial e) Adverse events: Any hypoxic episode (SpO 2 < 93%), bradycardia or hypotension requiring treatment, any other important adverse effect or treatment that is a deviation from existing protocol will be noted. f) A postoperative visit will be done the day after operation, and amnesia (loss of memory to endoscopy and intubation), any postoperative airway problem (hoarseness, sore throat) will be noted. If the patient is left with the tracheal tube in situ in view of difficult airway or if has undergone tracheostomy will be documented. g) Intubation Satisfaction Score (assessed the day after surgery) 1: excellent 2: good 3: fair 4: poor. page 6 / 6