| CTRI Number |
CTRI/2025/08/092586 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study Comparing the recovery after general anaesthesia between fentanyl and pentazocine |
|
Scientific Title of Study
|
A Randomised Prospective double blinded Observational study to Compare the Post General Anaesthesia recovery with Pentazocine and Fentanyl groups along with other preanaesthetic medications in a tertiary care hospital at Puducherry |
| 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 Snegaamarane K |
| Designation |
Postgraduate |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Room no 6, Dept of Pharmacology, Sri Venkateshwaraa Medical College Hospital and Research Centre,13-A,Pondy Villupuram Road, Ariyur,
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9677709420 |
| Fax |
|
| Email |
snegareshma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMSakthi Balan |
| Designation |
Head of the Dept of Pharmacology |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Room no 1, Dept of Pharmacology, Sri Venkateshwaraa Medical College Hospital and Research Centre,13-A,Pondy Villupuram Road, Ariyur,
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMSakthi Balan |
| Designation |
Head of the Dept of Pharmacology |
| Affiliation |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
| Address |
Room no 1, Dept of Pharmacology, Sri Venkateshwaraa Medical College Hospital and Research Centre,13-A,Pondy Villupuram Road, Ariyur,
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self funded Postgraduate thesis
Dr Snegaamarane K
Sri Venkateshwaraa Medical College Hospital and Research Centre
13-A Pondy-Villupuram Main Road, Ariyur, Puducherry - 605102,
India. |
|
|
Primary Sponsor
|
| Name |
Dr.Snegaamarane K |
| Address |
Dept. of Pharmacology, SRi Venkateshwaraa medical college hospital and research centre, 13-A, Pondy-Villupuram Main Road, Ariyur, Puducherry-605102 |
| Type of Sponsor |
Other [Self Funded Postgraduate thesis] |
|
|
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 Snegaamarane K |
Sri Venkateshwaraa Medical College Hospiital and Research Centre |
Room No 6,Dept of Pharmacology, Room no 10, Dept of Anesthesiology, Sri Venkateshwaraa Medical College Hospital And Research Centre, 13-A, Pondy-Villupuram Main road, Ariyur, Puducherry - 605102
Pondicherry
PONDICHERRY |
9677709420
snegareshma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC - Sri Venkateshwaraa Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G978||Other intraoperative and postprocedural complications and disorders of nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fentanyl |
Inj. FENTANYL 2mcg/kg i.v stat. only one dose before surgery |
| Comparator Agent |
Pentazocine |
Inj. PENTAZOCINE 0.6mg/kg i.v stat, only one dose before surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged between 18-60yrs.
2. Patients of both gender.
3. Patients with BMI 18.5 -22.9 (acc. to WHO Asian BMI scale )
4. Patients with controlled hypertension.
5. Patients with controlled Diabetes mellitus.
6. Patients with controlled hypothyroid.
7. Patients who are given Opioid free analgesia except induction.
8. Patients undergoing surgeries under plain General Anaesthesia with duration of 2-3hrs (like breast surgeries, CSOM (Chronic suppurative Otitis Media) surgeries, spine and other minor orthopedic surgeries, Total Abdominal Hysterectomy with Bilateral Salphingo-Oophorectomy,
Appendicectomy, Herniorrhaphy, lymph node excision on neck.,)
9. Patients who had smooth extubation process.
|
|
| ExclusionCriteria |
| Details |
1. Patients with following comorbidities (Acid Peptic Disease, Asthma, Pulmonary edema, Pulmonary fibrosis, Coronary artery disease)
2. Patients with difficulty airway.
3. Patients with known psychiatric illness.
4. Patients undergoing surgery with Duration of more than 3hrs.
5. Patients undergoing Laparoscopic surgery, adenotonsillectomy and other oral surgery.
6. Patients who are developing intraoperative events such as somatic arousal, pain perception, tachy/bradycardia. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of postoperative pain, nausea/vomiting and sore throat between fentanyl and pentazocine groups |
Patient would be monitored for every 5mins for 15mins, every 15mins for 1hr, every 30mins for 2hrs, 4hrs, 8hrs, 12hrs and 24hrs in the postoperative ward. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of Delirium, Respiratory depression,hoarseness of voice, cough between pentazocine and fentanyl groups. |
Patient would be monitored for every 5mins for 15mins, every 15mins for 1hr, every 30mins for 2hrs, 4hrs, 8hrs, 12hrs and 24hrs in the postoperative ward. |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
29/08/2025 |
| 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="6"
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
|
Patients were selected based on the inclusion criteria and those who are
selected were explained about the study and procedure involved and informed written consent will be
obtained. Patients who have given consent will be randomly divided into two
groups by sealed envelope technique (i.e) Group (P) and Group (F). Group (P) will be given Pentazocine along
with fixed standard preanesthetic medication and Group(F) will be given
Fentanyl along with fixed standard preanesthetic medication. All the selected patients
will be assessed preoperatively and demographic data will be collected and they will be given the preanesthetic medications and they will undergo surgery and they
will be monitored in the postoperative ward for the incidence of pain, nausea/vomiting, sore throat and delirium, respiratory depression, hoarseness of voice, cough for every 5mins for 15mins, every 15mins for 1hr, every 30mins for 2hrs,
4hrs, 8hrs, 12hrs and 24hrs. |