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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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