| CTRI Number |
CTRI/2022/08/045086 [Registered on: 30/08/2022] Trial Registered Prospectively |
| Last Modified On: |
07/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of paracetamol and paracetamol & dexmedetomidine combination for reduction of analgesic requirement and reduction of nausea and vomiting after operation in laparoscopic surgery. |
|
Scientific Title of Study
|
Comparison of paracetamol and paracetamol-dexmedetomidine combination on postoperative pain and postoperative nausea and vomiting after elective laparoscopic hysterectomy surgery: a randomized clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr GANGIREDDY HAREENDRANATH REDDY |
| Designation |
DNB Student |
| Affiliation |
Apollo Hospitals Bilaspur |
| Address |
Second floor OT Complex, Apollo Hospitals
Bilaspur
CHHATTISGARH
495006
India |
| Phone |
8328570698 |
| Fax |
|
| Email |
g.hareendra1961@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinit Kumar Srivastava |
| Designation |
Senior Consultant |
| Affiliation |
Apollo Hospitals Bilaspur |
| Address |
Second Floor OT Complex Apollo Hospitals
Bilaspur
CHHATTISGARH
495006
India |
| Phone |
9755557539 |
| Fax |
|
| Email |
drvinit75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinit Kumar Srivastava |
| Designation |
Senior Consultant |
| Affiliation |
Apollo Hospitals Bilaspur |
| Address |
Second Floor OT Complex Apollo Hospitals
Bilaspur
CHHATTISGARH
495006
India |
| Phone |
9755557539 |
| Fax |
|
| Email |
drvinit75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apollo Hospitals Bilaspur, Seepat Road, Lingiadih Village |
|
|
Primary Sponsor
|
| Name |
Apollo Hospitals Bilaspur |
| Address |
Seepat Road, Lingiadih Village, Bilaspur |
| Type of Sponsor |
Research institution and hospital |
|
|
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 GANGIREDDY HAREENDRANATH REDDY |
Apollo Hospitals Bilaspur |
Second Floor OT Complex, Seepat Road
Bilaspur
CHHATTISGARH |
8328570698
g.hareendra1961@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Apollo Hospitals Bilaspur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N859||Noninflammatory disorder of uterus, unspecified, (2) ICD-10 Condition: N859||Noninflammatory disorder of uterus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Paracetamol |
Paracetamol 4.5mg/kg bolus dose over 15 minutes,then demand
dose 1 mg/kg/hr with 30 min lockout interval and continuous dose 0.5 mg/kg/hr |
| Comparator Agent |
paracetamol dexmedetomidine combination |
Paracetamol 4.5mg/kg and dexmedetomidine 1mcg/kg bolus dose over 15 minutes, then
demand dose paracetamol 1mg/kg/hr(dexmedetomidine 0.1 mcg/kg/hr) with 30 min lockout interval and continuous
dose paracetamol 0.5mg/kg/hr(dexmedetomidine 0.05mcg) |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. ASA grade I and II
2. Scheduled for laparoscopic gynaecological surgery under general anesthesia |
|
| ExclusionCriteria |
| Details |
1.Known allergy to study drugs
2.Use of antiemetic drugs within 24 hrs of surgery
3.Morbid obesity(BMI>40)
4.Chronic use of opioids
5.Patients with hepatic,renal or cardiovascular dysfunction
6.Psychiatric patients |
|
|
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 |
| VAS Scoring and postoperative analgesic requirement |
VAS Scoring at 1,2,4,6 and 12th hour and analgesic
requirement in first 24 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative nausea and vomiting |
24 hr postoperative period |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "104"
Final Enrollment numbers achieved (India)="104" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/09/2022 |
| Date of Study Completion (India) |
30/12/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drvinit75@gmail.com].
- For how long will this data be available start date provided 01-05-2023 and end date provided 30-04-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Postoperative analgesic requirement and nausea & vomiting are common and distressing complaints after general anesthesia in laparoscopic surgery. Postoperative nausea and vomiting (PONV) incidence as high as 60-80% in high risk patients in laparoscopic surgeries. Use of opioids in postoperative period for pain relief is a high risk factor for PONV. So avoidance of opioids and use of paracetamol is another alternative for pain relief. But paracetamol alone is not effective for adequate pain relief. So we designed a study to compare the effectiveness of paracetamol and paracetamol dexmedetomidine combination for reduction of analgesic requirement and prevention of PONV in laparoscopic surgery. All selected patients will be randomized in to two groups (40 patients in each group) depending on the drug given. Group P - received paracetamol 4.5 mg/kg bolus dose over 15 min then demand dose 1 mg/kg/hr with 30 min lockout interval and continuous dose 0.5 mg/kg/hr Group PD - received paracetamol 4.5 mg/kg and dexmedetomidine 1 mcg/kg dose over 15 min, then demand dose paracetamol 1 mg/kg/hr (dexmedetomidine 1 mcg/kg/hr) with 30 min lockout interval and continuous dose paracetamol 0.5 mg/kg/hr (dexmedetomidine 0.05 mcg/kg/hr)
Primary outcome - VAS score at 1, 2, 4, 6 and 12 hr in postoperative period and analgesic requirement in first 24 hr period Secondary outcome - PONV incidence in first 24 hr postoperative period
Statistically analysis will be done after completion of study. |