| 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 |
|
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Primary Sponsor
|
| Name |
Himalayan Institute of medical sciences |
| Address |
Swami Ram nagar , Jolly Grant ,
Dehradun -248016 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K80||Cholelithiasis, |
|
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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 |
|
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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 |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
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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 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate role of chewing gum in pre-operative anxiety. |
In pre-op 15 min before entering the OT |
|
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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
|
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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%. |