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CTRI Number  CTRI/2024/11/076663 [Registered on: 12/11/2024] Trial Registered Prospectively
Last Modified On: 08/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of combined spinal - general anaesthesia versus general anesthesia alone for in robotic- assisted laparoscopic hernia repair surgeries - randomised controlled trial 
Scientific Title of Study   Comparison of combined spinal - general anaesthesia versus general anesthesia alone for intraoperative hemodynamic changes and postoperative analgesia in robotic- assisted laparoscopic hernia repair surgeries - randomised controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nandhini Ganesh  
Designation  junior resident  
Affiliation  Government Medical College, Nagpur 
Address  OTF, department of anesthesia, government medical college, nagpur

Mumbai
MAHARASHTRA
440003
India 
Phone  8830208247  
Fax    
Email  nansanandu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Yogesh Zanwar 
Designation  associate professor of anesthesia 
Affiliation  Government Medical College, Nagpur 
Address  otf, department of anesthesia, government medical college, nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  9423611718  
Fax    
Email  znyogesh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nandhini Ganesh  
Designation  junior resident  
Affiliation  Government Medical College, Nagpur 
Address  Department of anesthesia, gmc nagpur, medical square, nagpur 440003

Mumbai
MAHARASHTRA
440003
India 
Phone  8830208247  
Fax    
Email  nansanandu@gmail.com  
 
Source of Monetary or Material Support  
government medical college, Hanuman Nagar, Ajni Rd, Medical Chowk, Ajni, Nagpur, Maharashtra 440003 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
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 
Dr Nandhini Ganesh   Governement medical college nagpur  OT-F, second floor gmc hospital building, government medical college nagpur, medical square, Nagpur 440003
Nagpur
MAHARASHTRA 
8830208247

nansanandu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Gmc, Nagpur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  General anesthesia without subarachnoid block  General anesthesia using propofol 2mg/kg, midazolam 0.02 mg/kg, fentanyl 2 mcg/kg and muscle relaxants.  
Intervention  Subarachnoid block and general anesthesia  Hyperbaric Bupivacaine 0.5% with buprenorphine 150 mcg intrathecally prior to induction with general anesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients in the age group of 18 to 70 years of age
Non pregnant females
ASA I , II patients
Normal coagulation profile of patients - platelet count, Prothrombin time and International Normalised ratio
Patients posted for robotic- assisted laparoscopic hernia surgeries
 
 
ExclusionCriteria 
Details  Contraindication to spinal anaesthetic:
Allergy to local anesthetics
Abnormal curvature of spine- thoracolumbar kyphosis, scoliosis’
History of coagulation disorders
History of anticoagulant drug consumption
History of neuromuscular disorder - poliomyelitis, spinal muscular atrophies, multiple sclerosis
Infection at the site of spinal anaesthesia - L3 - L4 intervertebral space
Contraindication to buprenorphine:
Allergic reaction to buprenorphine
On opioid medication
Patients with history of COPD
4. Patients refusing to give consent to participate in the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of combined spinal- general anaesthesia and general anaesthesia alone in robotic assisted laparoscopic hernia repair surgeries by assessing
1. magnitude of intraoperative hemodynamic changes - Heart rate, Systolic blood pressure, diastolic blood pressure, Mean arterial blood pressure
2. pain assessment using VAS score at 1h, 6h, 24h after completion of surgery
 
1. Hemodynamic monitoring every 5 minutes till 20 minutes; then every 10 minutes till completion of surgery
2. pain assessment 1h, 6h and 24 hours after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the efficacy of combined spinal- general anaesthesia & general anaesthesia alone in robotic assisted surgeries by assessing
1. total dose of metoprolol required
2.surgeon satisfaction score
3. postoperative analgesia
duration i.e. time after completion of surgery to appearance of pain
number of times rescue analgesic were administered
 
1. Hemodynamic monitoring every 5 minutes till 20 minutes; then every 10 minutes till completion of surgery
2. pain assessment 1h, 6h & 24 hours after the surgery 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   20/11/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
  • After proper optimization of the patient, the patient’s vitals, airway and oral cavity are again examined on the day of the surgery. Nil by mouth status of the patient is confirmed on the day of surgery. 

  • Confirmation about the operation site taken from the surgeons. 

  • Written informed consent is taken from the patient and patient’s relatives after explaining about the procedure and about the study.

  • Patient is taken inside the operation theater and multiple parameters monitors measuring pulse, blood pressure, mean arterial pressure, oxygen saturation, respiratory rate, end tidal carbon dioxide and ECG tracing are attached. Intravenous access is secured, preferably with a wide bore needle - 18 G/ 20 G, preferably on the non operating side. Extension lines are attached to the wide bore intracath for easier intravenous access. 

  • Patients were premedicated with injection pantoprazole 40mg iv, injection ondansetron 4mg iv given slowly over five minutes and antibiotic as per the preference of the surgeon is administered. 

  • Patients were preloaded with lactated Ringer solution 15 mL/kg. 

  • For patients falling under Group A of the study, spinal anesthesia was administered before general anesthesia. Under all aseptic precautions subarachnoid block is given in third and fourth lumbar intervertebral space in sitting position using 25G Quincke spinal needle, with 0.5 % hyperbaric bupivacaine 10 mg and buprenorphine 150 microgram after confirming positive aspirate of cerebrospinal fluid and a free flow of cerebrospinal fluid.  Patient is immediately given a supine position and the operating table was adjusted in order to achieve a sensory level blockade of T6. Time of spinal injection is considered as time 0.

  • Onset of spinal anaesthesia is checked. Sensory blockade was checked with pin prick test and motor blockade was checked with modified Bromage scale. Maximum sensory blockade and motor blockade was noted.  After 20 minutes or time for maximal spinal action- T6 sensory blockade, whichever occurred earlier, general anaesthesia was induced.  

  • Both the patient groups A and B were preoxygenated with 100% Inspired Oxygen [FiO2] for three minutes on closed circuit with spontaneous ventilation. Patient sedated with  injection Midazolam (0.03 mg/kg) IV, injection Fentanyl (2 µg/kg) IV. Patients  induced with injection Propofol IV titrated to the loss of verbal response and abolition of eyelash reflex and the amount of drug administered will be noted and injection Vecuronium as a muscle relaxant will be administered in the dose of 0.1 mg/kg IV to facilitate intubation. Patient is oxygenated for 3 minutes after injection of the relaxant. 

  • Patients will be intubated with appropriate size endotracheal tube using conventional laryngoscopy with appropriate sized Macintosh laryngoscope with blade 3 or blade 4. The pilot balloon is inflated and air entry is checked on bilateral lung fields using a stethoscope. 

  • Patient is maintained on Oxygen, nitrous oxide and isoflurane. 

  • Isoflurane was used in the lowest possible concentration to keep MAP and HR within 20% of baseline and under deep plain of sedation. Intermittent boluses of Inj vecuronium 1mg was given to maintain the plane of anaesthesia. 

  • End tidal CO2 was maintained at 35 - 45 mm Hg and airway peak pressure maintained at <40 cm H2O . Appropriate interventions in ventilation were made if there was an increase in both the parameters. 

  • The time was noted when pneumoperitoneum using carbon dioxide gas was created and the pressure was kept between 12 and 15 mm Hg for all patients. The vitals during creation of pneumoperitoneum - heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure were documented. 

  • When the oxygen saturation dropped below 92% nitrous oxide was switched off and then the patient was maintained with 100% oxygen. Appropriate intraoperative interventions were done if there was a 20% change in the baseline vital parameters. 

  • If the blood pressure dropped to more than 20 % of the baseline levels then 100mL fluid boluses of either Ringer Lactate solution or Normal saline solution were given, if the blood pressure still not responded then Inj Mephenterine 6mg IV stat dose was given.  If the heart rate is less than 20% of baseline then patient will be treated with Inj Atropine 0.3 mg iv and repeated if required. 

  • If the heart rate and blood pressure increased to more than 20% of the baseline levels,  Inj. Metoprolol 0.1 mg/kg was given in titrated doses to maintain MAP. The total dose of metoprolol required intraoperatively during the surgery was recorded.  

  • Alpha-2 agonists were avoided due to their additional sedative properties. 

  • Monitoring was carried out by the attending anesthesiologist blinded to the technique. Intraoperative monitoring was done every 3 minutes after injection of drug intrathecally for the first 20 minutes and every 15 minutes after induction by general anaesthesia. Parameters measured are systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, and total dose of metoprolol required. 

  • After adequate spontaneous attempts at respiration are seen, the oropharynx was gently suctioned using soft suction catheter and reversal of the neuromuscular blockade was done with neostigmine 0.05mg/kg IV and glycopyrrolate 8 mcg/kg IV. After regaining complete consciousness, the patient was extubated. 

  • The time taken from closure of surgical incision till extubation is complete is noted as Recovery time.

  • Sensory and motor blockade was checked immediately after extubation and documented.  

  • Surgeons were asked to grade the operative field on the basis of bowel contractility and need for head low. It was quantified by Numeric Rating Scale from 1 - 10 with 1 meaning poor operative field and the need for maximum head low and 10 meaning best operative field with minimum head low. 

POST OPERATIVE:

  • Patients were shifted to the post operative room and observed for 2 hours for regression of spinal anaesthesia. Level of sensory blockade was noted. After shifting the patients to the respective ward, they were observed for 24 hours for post operative requirement of analgesia and respiratory depression. 

  • Post operative analgesia duration was defined as the time after completion of surgery to appearance of pain Visual Analog Scale score [VAS score]  >4.  Quality of analgesia was assessed using VAS on a 0-10 scale, where a score of 0 represents no pain and 10 was the worst pain imaginable.

  • Injection Diclofenac 75 mg intravenously was administered as rescue analgesia when the patient complained of pain or when the VAS score was >4. If Injection Diclofenac was ineffective in providing analgesia then Injection Fentanyl 25 mcg was given as a bolus dose. The time taken to administer the first rescue analgesic and the total use of rescue analgesia in 24 hours was noted. Various side effects like the incidence of nausea-vomiting, pruritus, and shivering were recorded.


 
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