| CTRI Number |
CTRI/2024/08/072335 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare incidence of shivering with dexmedetomidine and Nalbuphine when used with bupivacaine heavy for spinal anesthesia in lower abdominal surgeries |
|
Scientific Title of Study
|
A comparative study of incidence of Post spinal Anesthesia Shivering associated With use of Dexmedetomidine and Nalbuphine as an adjuvant to 0.5% hyperbaric bupivacaine in lower abdominal 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 Vinit Ojha |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Department of Anaesthesiology Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh
Varanasi UTTAR PRADESH 221005 India |
| Phone |
7605816869 |
| Fax |
|
| Email |
vinitojha1220@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shashi Prakash |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Department of Anaesthesiology Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh
Varanasi UTTAR PRADESH 221005 India |
| Phone |
9453047154 |
| Fax |
|
| Email |
reena216@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shashi Prakash |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Department of Anaesthesiology Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh
Varanasi UTTAR PRADESH 221005 India |
| Phone |
9453047154 |
| Fax |
|
| Email |
reena216@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences Banaras Hindu University Varanasi 221005 |
|
|
Primary Sponsor
|
| Name |
INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anesthesiology, 1st floor, Sir Sunderlal Hospital, Banaras Hindu University, Varanasi |
| 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 Vinit Ojha |
INSTITUTE OF MEDICAL SCIENCES |
Department of Anesthesiology, 1st floor, Sir Sunderlal Hospital Varanasi UTTAR PRADESH |
7605816869
vinitojha1220@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Medical Sciences BHU Varanasi |
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 |
Dexmedetomidine vs Nalbuphine |
To compare the incidence of Post spinal Anesthesia shivering associated with use of intrathecal Dexmedetomidine 5 mcg with 2.8 ml 0.5% Bupivacaine heavy and 0.5 mg Nalbuphine with 2.8 ml 0.5% Bupivacaine heavy in lower abdominal surgeries. |
| Intervention |
Spinal Anaesthesia |
Spinal anaesthesia will be administered at L2-L3 or L3-L4 interspace using a 25 G Quincke’s needle, in the lateral decubitus position. After confirming the free flow of 0.5% bupivacaine heavy with selected study drug (3 ml) was administered at a rate of 0.2 ml/s. Supplemental oxygen is delivered at a rate of 4 L/min via a face mask, and surgery commenced. Continuous monitoring of intraoperative vital signs are conducted, and fluid management will be tailored to the patients specific surgical procedure and body weight. Assessment and recording of the hemodynamic parameters done at 2 minutes interval for 10 min, then at 10 min interval for 1 hour, and after that every half hourly till 3 hours. Time for starting and incidences of shivering was noted. The level of sedation was also assessed, graded, and recorded simultaneously. Grading was done using the Ramsay sedation scale. Adverse effects such as itching, bradycardia, hypotension, postoperative nausea and vomiting were also compared in both the groups. Time of onset of shivering is noted and recorded as 0 hour. The grade of shivering along with vital parameters such as heart rate (HR), respiratory rate (RR), Blood Pressure (NIBP), Oxygen saturation (SpO2) and core body temperature was also recorded for total duration of 3 hrs. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient undergoing elective surgeries under spinal anaesthesia in whom any grade of shivering was noted.
2. Those who gave informed and written consent.
3. ASA Grade I and II |
|
| ExclusionCriteria |
| Details |
1. Those who refused consent.
2. Age less than 20 years
3. ASA Grade III and above
4. Patient allergic to Dexmedetomidine and Nalbuphine
5. Patient with uncontrolled Hypertension, cardiovascular disease, hepatic or renal disease, bronchospastic disease.
6. Psychiatric illness |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Crossley and Mahajan grading of intraoperative shivering. |
0 to 3 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in hemodynamic parameter |
0 to 3 hrs |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
25/08/2024 |
| 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)
|
Open to Recruitment |
| 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
|
In the realm of modern anaesthesia practice, the pursuit of excellence in patient care has been an enduring goal. One of the challenges that anaesthesiologists frequently encounter in their clinical practice is the management of post-spinal anaesthesia shivering, a common side effect that can lead to patient discomfort, compromised surgical conditions, and increased healthcare costs. This vexing issue has prompted researchers and clinicians to explore various pharmacological interventions to effectively alleviate this symptom. Shivering is a thermoregulatory response which is characterized by rhythmic muscle contractions that generate heat in an attempt to maintain normal body temperature. While shivering can occur in various clinical scenarios, its incidence is particularly high in patients undergoing spinal anaesthesia. Spinal anaesthesia is a widely employed technique for surgical procedures below the umbilicus due to its effectiveness and rapid onset of action. However, in many cases spinal anaesthesia is associated with shivering. Post-spinal anaesthesia shivering poses several challenges in clinical practice. it may cause patient and hemodynamic instability. It may also interfere with the precision and sterility of the surgical field, complicating the work of the surgical team and potentially prolonging surgical times. Lastly, shivering increases oxygen consumption and carbon dioxide production, which can strain the respiratory and cardiovascular systems, particularly in vulnerable patient populations such as the elderly or those with pre-existing medical conditions. To address these issues, anaesthesiologists have explored various pharmacological interventions to prevent and manage post-spinal anaesthesia shivering. Two drugs that have gained prominence in recent years for their potential efficacy in this regard are Dexmedetomidine and Nalbuphine. Dexmedetomidine is a highly selective α2-adrenergic agonist. It has sedative, analgesic, and anxiolytic properties. Its unique pharmacological profile has made it a versatile tool in the hands of anaesthesiologists. Dexmedetomidine acts by inhibiting the release of norepinephrine in the central nervous system, leading to reduced sympathetic outflow and a consequent reduction in shivering thresholds. Moreover, it does not suppress ventilation, making it an attractive option for patients undergoing spinal anaesthesia. Several studies have investigated the potential of Dexmedetomidine in reducing the incidence and severity of post-spinal anaesthesia shivering. These studies have reported promising results, demonstrating that Dexmedetomidine can effectively decrease the occurrence of shivering while maintaining hemodynamic stability and preserving respiratory function. Furthermore, its sedative and analgesic properties contribute to patient comfort and overall satisfaction. Nalbuphine is a lipophilic semi-synthetic opioid related to both oxymorphone and naloxone. It possesses an agonist action at the kappa – opioid receptor and antagonist action at the mu- opioid receptor to provide reasonably potent analgesia of visceral nociception. Nalbuphine binds to kappa receptors distributed in the spinal cord and brain to produce analgesia. It is mixed synthetic agonist-antagonist, which attenuates the mu- opioid effects and enhances the kappa-opioid effect. Numerous studies have investigated the use of Dexmedetomidine and Nalbuphine in preventing and treating post-spinal anaesthesia shivering. Some have reported favourable outcomes, showcasing potential of both this drugs to reduce the incidence and severity of shivering without significant adverse effects on respiratory or hemodynamic parameters. Additionally, direct comparisons between Dexmedetomidine and Nalbuphine in the context of post-spinal anaesthesia shivering are limited, necessitating a comprehensive study to provide clinicians with evidence-based guidance. While both Dexmedetomidine and show promise Nalbuphine in managing post-spinal anaesthesia shivering individually, the choice between them in clinical practice remains largely empirical. Clinicians lack definitive guidance on which drug to choose and at what dose, given the paucity of head-to-head comparative studies. This study aims to bridge this knowledge gap by conducting a rigorous comparison of Dexmedetomidine and Nalbuphine in the context of incidences of post-spinal anaesthesia shivering in lower abdominal surgeries. Through this comparative investigation, we seek to address several critical questions. |