| CTRI Number |
CTRI/2025/02/080645 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Prevention of nausea and vomiting after laparoscopic gynaecological surgeries by electrical stimulation of P6 acupoint. |
|
Scientific Title of Study
|
Transcutaneous electrical stimulation of P6 acupoint for prevention of post-operative nausea and vomiting in laparoscopic gynaecological surgeries. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kirti Nath Saxena |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Room No 304 3rd Floor BL Taneja Block Department of Anaesthesiology Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9968604215 |
| Fax |
|
| Email |
kirtinath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kirti Nath Saxena |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Room No 304 3rd Floor BL Taneja Block Department of Anaesthesiology Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9968604215 |
| Fax |
|
| Email |
kirtinath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhinde Kuber Jignesh |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Room No 304 3rd Floor BL Taneja Block Department of Anaesthesiology Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9619904235 |
| Fax |
|
| Email |
kuber.b22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated Lok Nayak Hospital, 2, Bahadur Shah Zafar Marg, near Delhi Gate,
Balmiki Basti, New Delhi, Delhi, 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Maulana Azad Medical College Campus,
2, Bahadur Shah Zafar Marg, near Delhi Gate,
Balmiki Basti, New Delhi, Delhi, 110002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kirti Nath Saxena |
Lok Nayak Hospital |
Department of Anaesthesiology, BL Taneja Block, Maulana Azad Medical College, Lok Nayak Hospital, JLN Marg, New Delhi
110002
Central
DELHI
Central
DELHI |
9968604215
kirtinath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pharmacologic PONV (Post-operative nausea and vomiting) prophylaxis |
Inj Ondansetron 4 mg IV will be administered intra-operatively 20 minutes prior to closure. |
| Intervention |
Transcutaneous electrical nerve stimulation (TENS) of P6 acupoint |
After induction of anaesthesia, the TENS 2.0®[UltraCare PRO] device will be applied over the P6 acupoint (located in between the tendons of palmaris longus and flexor carpi radialis, 4 cm proximal to the distal wrist crease).
Electrical Pulses of a duration of 15 minutes will be administered at intervals of 15 minutes (Maximum of 2 pulses intra-operatively). Post-operatively, 2 pulses of a duration of 15 minutes each will be administered at an interval of 15 minutes.The current output will be 0.4 micro-amperes (DC), the duration of the pulses will be 480 microseconds, and the frequency varied from 1-200 Hz depending on the output intensity (varying from 1-25 on the device) – as per the device specifications. The device has 10 different modes of electrical stimulation (as defined by the device manufacturer), and for the purpose of this study, mode ‘9’ will be selected – described as the acupuncture squeezing mode. The output intensity level will be increased gradually intra-operatively till thumb abduction is observed, confirming that the P6 point on the median nerve is being stimulated. Post-operatively, the intensity will gradually be increased till the level best tolerated by the patient. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Female patients scheduled to undergo short-duration (less than 2 hours) laparoscopic gynaecological surgeries.
2. Patients having American Society of Anaesthesiologists (ASA) Physical Status I or II. |
|
| ExclusionCriteria |
| Details |
1. BMI greater than 35 kg/m2
2. Patients having previous unpleasant experience with acupuncture ( for patients who have had prior exposure to acupuncture )
3. Patients with history of neuropsychiatric disorders
4. History of allergic reactions to medications used during Anaesthesia
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of Post-operative Nausea and Vomiting |
0-6 hours post-operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total Amount of Anti-Emetic Requirement |
6 hours post-operatively |
| Severity of Post-operative Nausea and Vomiting (Nausea NRS Scale, Composite Score) |
0, 1, 2, 6 hours post-operatively |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
25/02/2025 |
| 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 Yet Recruiting |
| 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
|
- Post-operative nausea and vomiting (PONV) is one of the most common causes of patient dissatisfaction after anaesthesia. It has an incidence of about 30 % in all post-surgical patients and upto 80 % in high-risk patients.
- Transcutaneous electrical nerve stimulation (TENS) over P6 acupoint (Nei Guan or Pericardium 6) has been reported to reduce the incidence of PONV. This acupoint is located in between the tendons of palmaris longus and flexor carpi radialis, 4 cm proximal to the distal wrist crease and 1 cm below the skin.
- In this study, we will aim to determine the efficacy of peri-operative P6 acupoint stimulation via TENS in the prevention of PONV in female patients undergoing short duration ( less than 2 hours ), laparoscopic gynaecological surgeries.
- A total of 114 patients with 57 patients in each group will be enrolled for the study. Patients will be explained about the study and written informed consent shall be taken.
- After induction of general anaesthesia, patients will receive either transcutaneous electrical nerve stimulation over P6 acupoint, or pharmacologic PONV prophylaxis using IV Ondansetron, as per their allocated group.
- We will be comparing and assessing the incidence of PONV in the early post-operative period ( 0-6 hours after surgery ) between the group receiving P6 acupoint stimulation and the group receiving intra-venous ondansetron intra-operatively.
- The severity of post-operative nausea and vomiting and the amount of anti-emetics required in the early post-operative period (0-6 hours) by patients in the two groups will be compared.
- This study will be conducted in the Department of Anaesthesiology, Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi over a period of 12 months ( 1 year )
- The study is a single-blinded, randomised, active-controlled study.
|