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CTRI Number  CTRI/2019/09/021071 [Registered on: 05/09/2019] Trial Registered Prospectively
Last Modified On: 04/09/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Complications during surgery in sitting position  
Scientific Title of Study   Sitting position and its complications in cervical laminectomy patients :A prospective observational study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrGeeta Singariya 
Designation  Professor 
Affiliation  Dr. S.N. medical collage, Jodhpur 
Address  Department of Anaesthesia Dr S N Medical College Jodhpur
Department of Anaesthesia,Dr. S.N. medical collage, Jodhpur
Jodhpur
RAJASTHAN
342001
India 
Phone  09414803554  
Fax    
Email  geetamanojkamal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrGeeta Singariya 
Designation  Professor 
Affiliation  Dr. S.N. medical collage, Jodhpur 
Address  Department of Anaesthesia Dr S N Medical College Jodhpur
Department of Anaesthesia Dr S N medical collage Jodhpur
Jodhpur
RAJASTHAN
342001
India 
Phone  09414803554  
Fax    
Email  geetamanojkamal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kamlesh Kumari 
Designation  Assistant Professor 
Affiliation  Goverment medical College, Pali, Rajasthan 
Address  Department of Anaesthesia, Goverment medical College, Pali, Rajasthan
Goverment medical College, Pali, Rajasthan
Pali
RAJASTHAN
306401
India 
Phone  8619126277  
Fax    
Email  kamlesh.gmch@gmail.com  
 
Source of Monetary or Material Support  
M D M Hospital Dr S N Medical College Jodhpur 
 
Primary Sponsor  
Name  M D M Hospital Dr S N Medical College Jodhpur 
Address  M D M Hospital Dr S N Medical College Jodhpur 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrGeeta Singariya  Main OT Complex First floor MDM hospital   Main OT Complex First floor Dept of Anaesthesia MDM hospital Dr. S.N. medical collage Jodhpur Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN 
9414803554

geetamanojkamal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr S N Medical College Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA physical status I /II of either sex
Patients posted for cervical laminectomy in sitting position under general anaesthesia 
 
ExclusionCriteria 
Details  Body mass index ≥ 30 kg/m2
Moderate to severe heart or lung disease(ASA ≥ III) Prior neurological deficits.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Incidence of complication  ICU discharge 
 
Secondary Outcome  
Outcome  TimePoints 
Haemodynamic variables
Need of postoperative ventilation and total days of ventilation and ICU stay 
ICU discharge 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/09/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This prospective, observational study will be carried out at MDM hospital, Dr S N Medical college, Jodhpur in patients aged 18-60 years, ASA I/II of either sex, scheduled for cervical laminectomy. A through preoperative evaluation will be done to assess the fitness. The  written informed consent will be taken from all the patients. All patients will be kept fasting overnight and will be pre-medicated with tablet alprazolam 0.25  mg and tablet ranitidine 150 mg orally night before surgery. 
After arrival of the patient in the operating room, standard monitoring - pulse oximetry, non-invasive arterial blood pressure and electrocardiography  will be attached. With all aspectic precautions radial artery will be cannulated under local anaesthesia for continous invasive blood pressure monitoring.  Baseline vital parameters like heart rate (HR), systolic blood pressure(SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), and arterial O2 saturation( SpO2) will be recorded in all patients. An i.v line will be secured with 18 gauge peripheral venous cannula and all patients will be preloaded with 10 ml/kg of crystalloid. All patients will be premedicated with i.v glycopyrrolate 0.2 mg, dexamethasone 0.15 mg kg-1  and fentanyl 2 µg kg-1. General anaesthesia will be induced with   propofol 2-3 mg  kg-1till loss of verbal response and tracheal intubation will be facilitated by vecuronium 0.1mg kg-1, intravenously.  After induction of anaesthesia, under all aseptic precautions right subclavian vein will be cannulated using seldingers technique. The sitting position will be made gradually over a period of 5 min with continous arterial pressure monitoring.
HR, SBP, DBP, MBP, SpO2, EtCO2 will be continuously monitored and will be recorded at baseline, after induction, after tracheal intubation, before making sitting position, during process of making sitting position every min till 5 min, after sitting position at 1, 2,3,4,5, 10 and 15 min. Subsequently, anaesthesia will be maintained using isoflurane achieving end-tidal concentration of 1.0 to 1.2% in a mixture of 50% air with 50% O2. Neuromuscular relaxation will be maintained with intermittent vecuronium bolus (0.02 mg/kg every 30 minutes). Ventilation will be adjusted to maintain EtCO2 between 30 and 35 mm Hg. Intraoperative rescue analgesia will be provided by intravenous fentanyl 0.5-1 μg/kg boluses as judged by increase in heart rate or systolic blood pressure by more than 20% of the baseline.   All patients will be given Injection ondansetron 0.1mg/kg prophylactically 30 minutes before reversal. At the end of surgery, patients will be turned supine and residual neuromuscular blockade will be reversed with i.v. neostigmine 50 µg.kg-1 and glycopyrrolate 10 µg.kg-1 and the trachea will be extubated when the patient is fully awake and breathing adequately and will be shifted to postanaesthesia care unit(PACU).
To evaluate occurrence of haemodynamic changes, an episode of hypotension will be defined as a decrease in the mean arterial pressure(MAP) 20% below baseline. Bradycardia will be defined as decrease in HR< 40 beats/min. Venous air embolism will be diagnosed by sudden and sustained drop of 5 mmHg of the end-tidal carbon dioxide (EtCO2). If hypotension (MBP<20% of baseline) would occur, 5 mg of ephedrine will be administered i.v. If hypotension would persist or recur three minutes after ephedrine injection, 50 µg of phenylephrine will be repeated every three minutes till blood pressure stabilizes. In the event of bradycardia 0.6 mg of atropine will be administered i.v. If VAE would occur, appropriate therapeutic measures will be taken immediately which involves, aspiration of air via the right atrial catheter, irrigation and packing of the wound, identification and coagulation of vessels.

      Intraoperative and postoperative complications of sitting position which include hypotension, VAE, PAE, quadriplegia, macroglosia and peripheral neuropathy will be noted in all patients and incidence  of each complication will be calculated. Intraoperative blood loss and need for blood transfusion, total duration of surgery, will be  noted. Need of postoperative ventilation and total days of ventilation and ICU stay will also be noted.

All the observations will be recorded in the proforma attached and analyzed statistically using appropriate statistical test.


 
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