FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2017/09/009588 [Registered on: 01/09/2017] Trial Registered Retrospectively
Last Modified On: 31/08/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Opioid free anesthesia vs Opioid based anesthesia 
Scientific Title of Study   Opioid free anesthesia: A safer option in obese patients. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shaman Bhardwaj 
Designation  Senior Resident 
Affiliation  Dayanand Medical College & Hospital 
Address  2231 38 C Chandigarh

Chandigarh
CHANDIGARH
160041
India 
Phone  8146312177  
Fax    
Email  shaman.bhardwaj13@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shaman Bhardwaj 
Designation  Senior Resident 
Affiliation  Dayanand Medical College & Hospital 
Address  2231 38 C Chandigarh

Chandigarh
CHANDIGARH
160041
India 
Phone  8146312177  
Fax    
Email  shaman.bhardwaj13@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shaman Bhardwaj 
Designation  Senior Resident 
Affiliation  Dayanand Medical College & Hospital 
Address  2231 38 C Chandigarh

Chandigarh
CHANDIGARH
160041
India 
Phone  8146312177  
Fax    
Email  shaman.bhardwaj13@gmail.com  
 
Source of Monetary or Material Support  
no external funding 
 
Primary Sponsor  
Name  Dayanand Medical College Hospital 
Address  DMCH, Tagore Nagar, Ludhiana. 141001 
Type of Sponsor  Research institution and hospital 
 
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 
Shaman Bhardwaj  Dayanand Medical College & Hospital Ludhiana  Department of anaesthesiology. (Operation theatres, Postoperative Recovery room)
Ludhiana
PUNJAB 		 8146312177

shaman.bhardwaj13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dayanand Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  a total of 80 patients aged 20 to 60 years with ASA II or III physical status with BMI of 30 or more scheduled for laparoscopic urological procedures under general anesthesia. ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Opioid Based Anesthesia (OBA)  All the patients received 1 mg of midazolam before the start of laparoscopy. Pre-oxygenation was done for three minutes before induction of anesthesia. In opioid based group, a bolus of fentanyl in the dose of 2 mcg/kg was given prior to intubation. Anesthesia was induced with propofol (2.5 – 3.5 mg/kg i.v.) and atracurium (0.5 mg/ kg i.v.), maintained on iv infusion of propofol (100- 200mcg/ kg /min) and intermittent boluses of atracurium (0.1mg/kg) titrated to a BIS between 40 and 60.Intermittent boluses of fentanyl 0.5mcg/kg were given to maintain adequate analgesia intraoperatively. 
Intervention  Opioid Free Anesthesia (OFA)  In opioid free group, a loading dose of dexmedetomidine (0.5 mcg/ kg i.v. over 10 minutes) was initiated. Anesthesia was induced with propofol (2.5 – 3.5 mg /kg i.v.) and atracurium (0.5 mg/ kg i.v.), maintained on i.v. infusion of dexmedetomidine (0.1 – 0.3 mcg/kg/hr), i.v. infusion of propofol (100- 200mcg/ kg /min) and intermittent boluses of atracurium(0.1mg/kg) titrated to a BIS between 40 and 60. Before incision a single dose of ketamine(0.5mg /kg i.v.) was given. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of age 20 to 60 years scheduled for laproscopic urological procedure
BMI > 30
 
 
ExclusionCriteria 
Details  Patients with history of known allergies to study drugs
Opioid use one month prior to surgery
Chronic opioid addiction
Inability to comprehend visual analog scale Pregnant or lactating mothers
History of significant hepatic, renal or cardiac disease 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary Outcome: Postoperative consumption of narcotic in recovery room during 24 hours post operatively.
Secondary outcomes:
Time of first rescue analgesic administration, extubation, orientation and PACU discharge times
 		 24 hours post operatively
 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes:
Time of first rescue analgesic administration, extubation, orientation and PACU discharge times  		 24 HOURS 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   06/04/2017 
Date of Study Completion (India) 06/08/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   1.Benyamin R, Trescot AM, Datta S, Buenaventura R et al. Opioid complications and side effects. Pain Physician. 2008;11(2 Suppl):S105-20. 2 Tan, M. and Law, L.S.Optimising pain management to facilitate enhanced recovery after surgery pathways. Can J Anesth. 2015;62:203- 218. 3. Mefkur Bakana, Tarik Umutoglua, Ufuk Topuza, Harun Uysala. Opioid-free total intravenous anesthesia with propofol, dexmedetomidine and lidocaine infusions for laparoscopic cholecystectomy: a prospective, randomized, double-blinded study.Rev Bras Anestesiol. 2015;65(3):191-9. 4.P. Ziemann-Gimmel, A. A. Goldfarb, J. Koppman and R. T. Marema. Opioid-free total intravenous anaesthesia reduces postoperative nausea and vomiting in bariatric surgery beyond triple prophylaxis. BJA doi:10.1093/bja/aet551.  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This was a prospective, randomized, double blind controlled study on a total of 80 patients of age 20 to 60 years with ASA II or III physical status and BMI of 30 or more scheduled for laproscopic urological procedures under general anaesthesia.

The objective of this study was to evaluate efficacy of Opioid Free Anaesthesia with propofol, dexmedetomidine, lignocaine and ketamine in obese patients posted for urological laproscopic procedures and its effects on postoperative analgesic consumption, haemodynamic stability and incidence of respiratory depression.

Postoperative pain was assessed using Visual Analogue Score (VAS) 30 minutes after recovery, hourly after 2 hours and every 4hourly for 24 hours. Mean analgesic consumption, time of rescue analgesic administration, PACU discharge times were also noted.

 
Close