Comparison of the efficacy of IV Dexmedetomidine, Pethidine & Tramadol for prevention of perioperative shivering.

Phase 4

Not yet recruiting

• Conditions: Urinary calculus, unspecified,

• Registration Number: CTRI/2024/03/063501
• Lead Sponsor: IQ CITY MEDICAL COLLEGE

Brief Summary

**Proposed topic of research**:

**“COMPARISONOF THE EFFICACY OF INTRAVENOUS DEXMEDETOMIDINE, PETHIDINE & TRAMADOL FORPREVENTION OF PERIOPERATIVE SHIVERING IN PATIENTS UNDERGOING SPINAL ANAESTHESIAFOR UROLOGICAL SURGERIESâ€**

 **Objectives of proposed research**:

 **GENERAL OBJECTIVE**

a)     To compare the efficacy ofintravenous Dexmedetomidine, Pethidine & Tramadol in prevention of perioperative shivering

**SPECIFIC OBJECTIVE**

a)     Todetermine andcompare the efficacy of intravenous Dexmedetomidine, Pethidine & Tramadolin prevention of perioperative shivering

b)     To compare the level ofsedation caused by these study drugs

c)     To determine the adverseeffects (if any) caused by these three drugs

**Backgroundof present study****:**

Spinalanaesthesia is widely used as a safe anaesthetic method for both elective andemergency urological surgeries providing a faster onset and effective motor andsensory blockade. Shivering is a known complication of spinal anaesthesia. Itoccurs in 40 to 70% of patients undergoing surgery under spinal anaesthesia .

Shiveringcauses increased metabolism and is associated with marked rise in oxygenconsumption (up to 100 – 600%) of the tissue, thereby causing marked stress onthe circulatory and respiratory systems. It also causes discomfort andincreases surgical pain to the patients. It is associated with increase inintra-ocular pressure and intra cranial pressure . Shiveringcauses adverse peri operative outcomes like wound infection, increased surgicalsite bleeding and morbid cardiac events. It may also cause arterial hypoxemia,lactic acidosis and interfere with pulse rate, blood pressure (BP) andelectrocardiographic (ECG) monitoring .

 Variousmethods, available to control shivering during anaesthesia, includenon-pharmacological and pharmacological methods. Non-pharmacological methodsusing equipment are effective but expensive and lack practicality while drugslike Pethidine, Tramadol, Clonidine, Dexmedetomidine, Ketamine, Nefopam aresimple, cost-effective and easy to implement.

 Theaim of this study is to compare the efficacy, potency, haemodynamic effects,and side effects of intravenous Dexmedetomidine, Pethidine & Tramadol whengiven in pre-emptive dose to control shivering during spinal anaesthesia. Wewill further study the efficacy of the above drugs for the treatment ofperioperative shivering

**6.Methodology:**

 An experimental study will be carried outamong patients undergoing urological surgeries in IQ City Medical College &Hospital in Durgapur, West Bengal. Data will be collected over the 18 monthsperiod. Preoperative evaluation of the patients will be done on the day beforesurgery and all of them will be informed about the study. Written and informedconsent will be obtained. On day of surgery, data will be obtained &statistical analysis will be done with help of appropriate statisticalsoftware.

 **7.Expected Outcome:**

The present study notonly will give us a picture of the efficacy of intravenous Dexmedetomidine, Pethidine,and Tramadol in preventing shivering after spinal anaesthesia in patientsundergoing urological surgery, but will also reflect the intraoperativehemodynamic stability and adverse side effects of the three study drugs.Moreover, it will tell us about patients’ compliance.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-02-29
• Study Start: 2024-12-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

American Sociey of Anaesthesiologists (ASA) Physical status 1 & 2 Patients posted for Urological Surgery Undergoing Spinal Anaesthesia.

Exclusion Criteria

• Patient refusal B.
• Immunocompromised patients C.
• Local site infection D.
• Known allergy to local Anaesthesia and study drug E.
• Cardio-pulmonary, renal or hepatic impairment F.
• Known history of substance (except tobacco) or alcohol abuse G.
• An initial axillary temp >37.5°c or<35.5°c H.
• Blood transfusion during surgery I.
• Hypo or hyperthyroidism J.
• Convulsion or psychiatric disorder K.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The present study not only will give us a picture of the efficacy of intravenous Dexmedetomidine, Pethidine, and Tramadol in preventing shivering after spinal anaesthesia in patients undergoing urological surgery.	At baseline

Secondary Outcome Measures

Name	Time	Method
It will also reflect the intraoperative hemodynamic stability & adverse side effects of the three study drugs. Moreover, it will tell us about patients’ compliance.	At baseline

Trial Locations

Locations (1)

IQ CITY MEDICAL COLLEGE AND HOSPITAL; 🇮🇳 Barddhaman, WEST BENGAL, India

IQ CITY MEDICAL COLLEGE AND HOSPITAL

🇮🇳Barddhaman, WEST BENGAL, India

Dr Debtanu Mal

Principal investigator

8348777720

maldebtanu@gmail.com