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CTRI Number  CTRI/2023/11/059949 [Registered on: 17/11/2023] Trial Registered Prospectively
Last Modified On: 15/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To compare the effects of two different groups of drugs on gastric motility  
Scientific Title of Study   Intraoperative opioid versus non-opioid induced delay in perioperative gastric emptying: A comparative randomised double blind controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deekshanth Ramakrishnan 
Designation  Post Graduate  
Affiliation  Karnataka Institute of Medical Sciences  
Address  Room No. 26, Vivek Boys Hostel, Karnataka Institute of Medical Sciences, PB Road, Vidya Nagar, Hubballi, Karnataka-580021

Dharwad
KARNATAKA
580021
India 
Phone  7010063083  
Fax    
Email  deekshanth0812@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Madhuri S Kurdi 
Designation  Professor and head  
Affiliation  Karnataka Institute of Medical Sciences 
Address  Dept. of Anaesthesiology Karnataka Institute of Medical Sciences, Hubballi-580021

Dharwad
KARNATAKA
580021
India 
Phone  9449590556  
Fax    
Email  drmadhuri_kurdi@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Madhuri S Kurdi  
Designation  Professor and head 
Affiliation  Karnataka Institute of Medical Sciences 
Address  Dept. of Anaesthesiology Karnataka Institute of Medical Sciences, Hubballi-580021

Dharwad
KARNATAKA
580021
India 
Phone  9449590556  
Fax    
Email  drmadhuri_kurdi@yahoo.com  
 
Source of Monetary or Material Support  
Karnataka Institute of Medical Sciences, Hubballi 
 
Primary Sponsor  
Name  Dr Deekshanth Ramakrishnan  
Address  Room No. 26, Vivek Boys Hostel, Karnataka Institute of Medical Sciences, PB Road, Vidya Nagar, Hubballi, Karnataka-580021 
Type of Sponsor  Other [Self ] 
 
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 Deekshanth Ramakrishnan  Karnataka Institute of Medical Sciences   Department of Anaesthesiology Karnataka Institute of Medical Sciences, Hubballi-580021
Dharwad
KARNATAKA 		 7010063083

deekshanth0812@gmai.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kims,Hubballi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  IV Fentanyl  2mcg/kg in 100ml NS over 15mins 
Comparator Agent  IV Ketamine   2mg/kg in 100ml NS over 15mins 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patients belonging to ASA physical status I and II
2)Age 18-60 years, belonging to either gender
3)Patients giving informed written and valid consent
4)Patients undergoing upper/lower ureteric and urethral procedures under spinal anaesthesia
 
 
ExclusionCriteria 
Details  1)Patients with diabetes mellitus, chronic renal failure
2)Pregnant females
3)Patients on any drugs causing a delay in gastric emptying like aluminum hydroxide, antacids, calcium channel blockers, diphenhydramine, L-Dopa, lithium and tricyclic antidepressants(TCAs)
• Patients on pantoprazole and metaclopramide
• Patients having hypersensitivity to any of the study drugs
• Patients with prior history of gastrointestinal disease and gastrointestinal reflux disease
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To detect opioid-induced delay in gastric emptying in the perioperative period  Gastric residual volume will be measured before induction of anaesthesia, immediately after surgery, 2 hours postoperative, 6 hours postoperative  
 
Secondary Outcome  
Outcome  TimePoints 
1)To find the efficacy of gastric ultrasound as a bedside tool for assessing the quality & quantity of gastric contents in the peri-operative period.
2)To assess the delay in gastric emptying produced by ketamine.
3)To find out if pain produces delay in gastric emptying.
 		 Gastric residual volume will be measured just be induction of anaesthesia, immediately after surgery, 2hours postoperative, 6hours postoperative  
 
Target Sample Size   Total Sample Size="93"
Sample Size from India="93" 
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   Phase 4 
Date of First Enrollment (India)   25/11/2023 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Analgesics are widely prescribed for acute and chronic pain. Opium is one of the oldest herbal
medicines currently used as an analgesic, sedative and antidiarrhoeal. The effects of opium are
principally mediated by the μ-, κ- and δ-opioid receptors. Common adverse effects of opioid
administration include sedation, dizziness, nausea, vomiting, delayed gastric emptying,
constipation, dependency and tolerance, and respiratory depression.

Most of their effects on gastrointestinal motility and secretion result from suppression of neural
activity. Inhibition of gastric emptying, increase in sphincter tone, changes in motor patterns, and
blockage of peristalsis result from opioid use. Sedation and general anaesthesia depress or
impede the physiological mechanisms that protect against aspiration (the tone of the lower
oesophageal sphincter and upper airway reflexes).

Although the detrimental effects of opioids on the lower gastrointestinal tract are well known,
the opioid health crisis has certainly brought this to the forefront of gastroenterology with recent
data regarding their impact on esophageal and gastroduodenal motility. Aspiration of gastric
contents is a rare but nevertheless important cause of anaesthetic mortality and morbidity. It is
recognised that opioids can delay gastric emptying and the use of these drugs may increase the
risk of peri-operative aspiration of gastric contents. The delay in gastric emptying may also
reduce the effectiveness of oral analgesics given postoperatively
.

Opiod-free anaesthesia is now a new favourite of anaesthesiologists in journals and in
conferences as a topic of lecture, symposium and panel discussion. However, assessment of
perioperative gastric contents relies almost exclusively on clinical history that may not be
reliable. Older studies have done assessment of perioperative gastric volume by other techniques
such as acetaminophen absorption test, electrical bioimpedance technique, scintigraphy, etc
.
Nowadays, there is a growing interest in the use of bedside ultrasonography to assess gastric
contents and volume. The ISA national preoperative guidelines weakly recommend gastric
ultrasound as a bedside tool for assessing the quality and quantity of gastric contents in the
preoperative period

. The current study will evaluate the intraoperative opioid versus non-
opioid induced delay in perioperative gastric emptying using gastric ultrasound as a bedside tool.
 
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