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CTRI Number  CTRI/2024/01/061074 [Registered on: 02/01/2024] Trial Registered Prospectively
Last Modified On: 19/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Quasy experimental 
Study Design  Other 
Public Title of Study   Chewing gum vs accupressure band in prevention of nausea and vomiting after laparoscopic cholecystectomy  
Scientific Title of Study   To study the effectiveness of preoperative sugar free chewing gum and p6 pericardial point accupressure as an adjuvant for attenuation of post operative nausea and vomiting in patients undergoing laproscopic cholecystectomy under general anaesthesia  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Veena Asthana 
Designation  Professor  
Affiliation  Swami Rama Himalayan University  
Address  Department of Anaesthesia Himalayan Institute of Medical Sciences Swami Rama Himalayan University Swami Ram nagar Jolly Grant , Dehradun

Dehradun
UTTARANCHAL
248140
India 
Phone  9719529195  
Fax    
Email  veenaasthana@srhu.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chirag Ahuja 
Designation  PG resident  
Affiliation  Swami Rama Himalayan University  
Address  Department of Anaesthesia Himalayan Institute of Medical Sciences Swami Rama Himalayan University Swami Ram nagar Jolly Grant , Dehradun

Dehradun
UTTARANCHAL
248140
India 
Phone  8171242605  
Fax    
Email  chigsahuja1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Chirag Ahuja 
Designation  PG resident  
Affiliation  Swami Rama Himalayan University  
Address  Department of Anaesthesia Himalayan Institute of Medical Sciences Swami Rama Himalayan University Swami Ram nagar Jolly Grant , Dehradun

Dehradun
UTTARANCHAL
248140
India 
Phone  8171242605  
Fax    
Email  chigsahuja1@gmail.com  
 
Source of Monetary or Material Support  
Swami Rama Himalayan University Jolly Grant, Dehradun,248140 
 
Primary Sponsor  
Name  Himalayan Institute of medical sciences  
Address  Swami Ram nagar , Jolly Grant , Dehradun -248016 
Type of Sponsor  Private 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 
Dr Veena Asthana  Himalayan Institute of Medical Sciences   Pre op area , operation theatre 1st floor , Department of anesthesia Himalyan Institute of Medical Sciences Swami Ram Nagar Jolly Grant , Dehradun
Dehradun
UTTARANCHAL 
9719529195

veenaasthana@srhu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Swami Rama Himalayan University   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K80||Cholelithiasis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group 1   Standard general anaesthesia  
Comparator Agent  Group 2  Standar general anaesthesia plus Wrigleys extra sugar free chewing gum 3 times in pre op for 15-30 min each with 2 hours interval from induction  
Comparator Agent  Group 3  Standard general anaesthesia plus bilateral p6 point accupressure by pressure band (drug free).To be applied 3 figerbreadths proximal to distal crease on the plantar surface of the wrist between palmaris longus and flexor carpi radicalism tendon , since when the patient comes in pre-op till 72 hrs after surgery  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA grade i and ii patients with intact mental status posted for laproscopic cholecystectomy under general anaesthesia,using LMA after obtaining written and informed consent  
 
ExclusionCriteria 
Details  Refused to participate in study
Contraindication to chewing gum
Impaired pharyngeal /oesophageal function (eg bulbar palsy , achalasia )
Phenylketonuria (contraindication to sweetner aspartame in chewing gum )
Full upper or lower denture (not feasible to chew gum )
Contraindication to any protocolised antiemetic drug (prophylaxis , randomised interven or rescue )
Planeed postoperative mechanical ventilation
Patient with history of postoperative nausea vomiting in previous surgery
Edentulate patient who are unable to chew gum
Allergic to any of used drug
Patient having any contraindication for applying for arm pressure eg burns , wounds , trauma , fistula
Pregnant and breast feeding females  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To study effectiveness of preoperative sugar free chewing gum vs p6 pericardial point accupressure as an adjuvant in preventing post operative nausea and vomiting, and decrease in demand of rescue antiemetic   At 24, 48 and 72 hrs  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate role of chewing gum in pre-operative anxiety.   In pre-op 15 min before entering the OT 
 
Target Sample Size   Total Sample Size="186"
Sample Size from India="186" 
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)   18/01/2024 
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="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   Postoperative nausea vomiting (PONV) is one of the most common complications in the patients undergoing surgeries under general anaesthesia, although often neglected. Postoperative nausea and vomiting (PONV) is a prevalent and distressing complication experienced by patients undergoing surgeries under general anesthesia. It is considered one of the most common adverse events in the postoperative period, affecting a significant number of surgical patients. PONV not only causes discomfort and distress to patients but can also lead to prolonged hospital stays, increased healthcare costs, and patient dissatisfaction with their surgical experience.

It can further affect patient satisfaction and leads  to hematoma ,dehydration, electrolyte imbalance, bleeding, complications of surgical sites, wounds, aspiration in postoperative patients

Commonly used older, traditional antiemetics for PONV include the anticholinergics (scopolamine), phenothiazines (promethazine), antihistamines (diphenhydramine), butyrophenones (droperidol) and benzamides (metoclopramide). These antiemetics have adverse effects such as dry mouth, sedation, hypotension, extrapyramidal symptoms, dystonic effects and restlessness.

The newest class of antiemetics used for the prevention and treatment of PONV are the serotonin receptor antagonists (ondansetron, granisetron). These antiemetics do not have the adverse effects of the older, traditional antiemetics. Headache and dizziness are the main adverse effects of the serotonin receptor antagonists in the dosages used for PONV.

This has lead to the emergence of interest in therapies which have advantage of low cost, limited side-effects and patient acceptability . The above beign pharmacological/ non-pharmacological therapies like hypnosis , relaxation imagery, music therapy aromatherapy, acupressure (Apr) , P6 point stimulation with acupuncture(Apu) /acupressure, ginger, chewing gum and others. 

Among the above mentioned therapies chewing gum and acupressure have been attracting attention,  because of patient acceptability and lower side effects   but still there are very less studies done on them and no comparison has been done between the two.

Chewing gum, p6 point acupressure is   believed to have a  potential as a novel , drug free alternative treatment for PONV, therefore we aim to conduct a randomised comparative study to evaluate the safety and efficacy of preoperative chewing gum , pericardial p6 point acupressure as an adjuvant  for attenuation of post op nausea and vomiting. 

If it is noted that chewing gum or pericardial p6 point is effective and its efficacy is comparable to the other pharmacological drugs, this study will be of benefit to millions of patients around world.

Sample size

Primary Outcome = Comparison of Post-Operative Incidence of Nausea and Vomiting 

 For estimation of sample size, the following formula has been used

n =     [z1-α/2.√2P(1-P) + z1-β.√{P1(1-P1) + P2(1-P2)}]2

           _________________________________________________
                                 (P1-P2)2                                                                       

where

Zα/2 is the critical value of the Normal distribution at α/2 (for a confidence level of 95%, α is 0.05 and the critical value is 1.96)

Zβ is the critical value of the Normal distribution at β (for a power of 80%, β is 0.2 and the critical value is 0.842)

p1 and p2 are the expected sample proportions of the two groups.

Assumptions:

The sample size calculated was 62 patients per group depending upon 20% reduction in postoperative nausea and vomiting as clinically significant difference and α error of 5%. 
 
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