| CTRI Number |
CTRI/2025/02/081101 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
26/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In the study, people are randomly given either Nalbuphine or Dexmedetomidine with Bupivacaine, and the researchers will compare which one is more effective at stopping shivering after the procedure.
|
|
Scientific Title of Study
|
Intrathecal Nalbuphine versus Dexmedetomidine as adjuvants with Bupivacaine in prevention of Post Spinal Shivering - A Randomized Controlled Trial |
| 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 Nivetha Manikandan |
| Designation |
1st year PG |
| Affiliation |
Aarupadai veedu medical College and hospital |
| Address |
Department of anesthesiology First floor A block Aarupadai veedu
medical college and hospital Kirumambakkam Pondicherry
Pondicherry
PONDICHERRY
607402
India
Department of anesthesiology First floor A block Aarupadai veedu
medical college and hospital Kirumambakkam Pondicherry
Pondicherry
PONDICHERRY
607402
India
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9108846884 |
| Fax |
|
| Email |
nivethamani22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Ezhil Rajan |
| Designation |
HOD and Professor |
| Affiliation |
Aarupadai veedu medical College and hospital |
| Address |
Department of anesthesiology First floor A block Aarupadai veedu
medical college and hospital Kirumambakkam Pondicherry
Pondicherry
PONDICHERRY
607402
India
Department of anesthesiology First floor A block Aarupadai veedu
medical college and hospital Kirumambakkam Pondicherry
Pondicherry
PONDICHERRY
607402
India
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9843030074 |
| Fax |
|
| Email |
ezhilrajan96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nivetha Manikandan |
| Designation |
1st year PG |
| Affiliation |
Aarupadai veedu medical College and hospital |
| Address |
Department of anesthesiology First floor A block Aarupadai veedu
medical college and hospital Kirumambakkam Pondicherry
Pondicherry
PONDICHERRY
607402
India
Department of anesthesiology First floor A block Aarupadai veedu
medical college and hospital Kirumambakkam Pondicherry
Pondicherry
PONDICHERRY
607402
India
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9108846884 |
| Fax |
|
| Email |
nivethamani22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology First floor A Block Aarupadai Veedu medical college and hospital Kirumambakkam Pondicherry 607402 India |
|
|
Primary Sponsor
|
| Name |
Aarupadai veedu medical college and hospital |
| Address |
Aarupadai veedu medical college and hospital Kirumampakkam
Pondicherry cuddalore highway Pondicherry |
| Type of Sponsor |
Private 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 Nivetha Manikandan |
Aarupadai Veedu medical college and hospital |
Department of
Anaesthesiology First
floor A block
Kirumampakkam
Cuddalore pondicherry
highway Pondicherry
Pondicherry
PONDICHERRY
Pondicherry
PONDICHERRY |
9108846884
nivethamani22@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee Aarupadai Veedu Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S720||Fracture of head and neck of femur, (2) ICD-10 Condition: S822||Fracture of shaft of tibia, (3) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (4) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (5) ICD-10 Condition: S723||Fracture of shaft of femur, (6) ICD-10 Condition: O||Medical and Surgical, (7) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A: patients will receive intrathecal Nalbuphine |
Group A: patients will receive 3ml of 0.5% hyperbaric Bupivacaine with 0.1ml of 1mg Nalbuphine and assessed for post spinal shivering and other outcomes |
| Intervention |
Group B: patients will receive intrathecal Dexmedetomidine |
Group B: patients will receive 3ml of 0.5% hyperbaric Bupivacaine with 0.1ml of 10µg Dexmedetomidine and assessed for post spinal shivering and other parameters |
| Comparator Agent |
NOT APPLICABALE |
NO APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group 18 to 60 years
2. ASA I and ASA II
3. Patient planned for elective lower
abdominal and lower limb surgeries under
spinal anaesthesia
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Contraindication for spinal anaesthesia
3. BMI more than 30
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the incidence and severity of post spinal shivering with intrathecal Nalbuphine and Dexmedetomidine as an adjuvant with Bupivacaine in spinal anaesthesia.
|
7 hours intraoperatively and postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess:
Hemodynamic parameters (Heart Rate, Mean Arterial Blood Pressure, Oxygen Saturation, Respiratory Rate and Temperature)
Sedation (Ramsay Sedation Score)
Adverse events if any (Nausea, vomiting and drug allergies)
|
7hours intraoperatively and postoperatively |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
28/02/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Shivering is often seen after spinal anaesthesia and it is associated with adverse effects and causes discomfort in post spinal patients. In this study we comparing the efficacy of Intrathecal Nalbuphine and Dexmedetomidine for prevention of post spinal shivering. |