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CTRI Number  CTRI/2024/10/074748 [Registered on: 04/10/2024] Trial Registered Prospectively
Last Modified On: 02/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare post-operative effect of skin infiltration of dexmedetomidine with ropivacaine versus dexamethasone with ropivacaine in midline neck surgery under general anaesthesia.  
Scientific Title of Study   A comparative study of post-operative analgesic efficacy of 0.25 percentage ropivacaine with dexmedetomidine versus dexamethasone as an adjuvant in bilateral superficial cervical plexus block for midline neck surgery under general anaesthesia.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Devendra Joshi 
Designation  Resident doctor 
Affiliation  Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, General Ot Complex ,1st Floor, Dhiraj Hospital , Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre ,Piparia, Wagodiya,vadodara

Vadodara
GUJARAT
391760
India 
Phone  9970380035  
Fax    
Email  devendra.joshi1995@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Tejash H Sharma 
Designation  Professor  
Affiliation  Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, General Ot Complex ,1st Floor, Dhiraj Hospital , Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre , Piparia, Wagodiya,vadodara.

Vadodara
GUJARAT
391760
India 
Phone  9427332100  
Fax    
Email  drtejash@gmail.com  
 
Details of Contact Person
Public Query  
Name  Devendra Joshi 
Designation  Resident doctor 
Affiliation  Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department, General Ot Complex ,1st Floor, Dhiraj Hospital , Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre ,Piparia, Wagodiya,vadodara

Vadodara
GUJARAT
391760
India 
Phone  9970380035  
Fax    
Email  devendra.joshi1995@gmail.com  
 
Source of Monetary or Material Support  
Sumandeep Vidyapeeth Deemed to be University, Piparia, Taluka Waghodiya, Dist. Vadodara, 391760, Gujarat, Inida. Material support. 
 
Primary Sponsor  
Name  Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Wagodhia , Pipariya, Vadodara, Gujarat , India Pincode- 391760 
Type of Sponsor  Private medical college 
 
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 
DrDevendra Joshi  Dhiraj Hospital, Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre  Anaesthesia Department , General Ot Complex, 2nd Floor, Dhiraj Hospital , Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre , Sumandeep Vidyapeeth Deemed to be University, Wagodhia , Pipariya, Vadodara. Pincode 391760
Vadodara
GUJARAT 		 9970380035

devendra.joshi1995@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SUMANDEEP VIDYAPEETH INSTITUTIONAL ETHICS COMMITEE  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  Inj.Dexamethasone with ropivacaine  Inj.Dexamethasone 1mg as an adjuvant with 0.25percentage ropivacaine in bilateral superficial cervical plexus block under general anaesthesia post operative analgesic action observe every 2hourly till 24 hours. 
Intervention  Inj.dexmedetomedine with ropivacaine   Inj.Dexmedetomedine 50 mcg as an adjuvant with 0.25percentage ropivacaine in bilateral superficial cervical plexus block under general anaesthesia and post operative analgesic action observe every 2hourly till 24 hours. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients willing to participate in the studys.
2. Patients of ASA Grade I and II of either gender.
3. Patients undergoing elective midline neck surgeries under general
anaesthesia
4. Age of patients 18-65 years.  
 
ExclusionCriteria 
Details  1 Patient refusal.
2 Patient not nil by mouth.
3 Patients with uncontrolled systemic disease like heart disease, liver disease,
kidney disease.
4 Patients with anaemia, shock, septicaemia, uncontrolled hypertension.
5 Patients with bleeding and coagulation disorders
6 Infection at site
7 History of upper mediastinal irradication
8 Inability to tolerate general anaesthesia
9 Any neck metastasis
10 History of previous head and neck surgery
11 Hoarse and weak voice 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To check post operative reduction in opioids requirement with drug
0.25% ropivacaine with dexmedetomidine versus dexamethasone as an
adjuvant given in bilateral superficial cervical plexus block for midline neck
surgery under general anaesthesia. 		 Pain assessment every 2hrly post operatively from 0hr to 24hr. 
 
Secondary Outcome  
Outcome  TimePoints 
Sedation score & any side effects.  Post-operatively after extubation & then at 2 hourly till 24 hours. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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/ Phase 4 
Date of First Enrollment (India)   17/10/2024 
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="0"
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  

A comparative study of post-operative analgesic efficacy of 0.25 percentage ropivacaine with dexmedetomidine versus dexamethasone as an adjuvant in bilateral superficial cervical plexus block for midline neck surgery under general anaesthesia. 

A study to compare post-operative effect of skin infiltration of   dexmedetomidine with ropivacaine versus dexamethasone with ropivacaine in midline neck surgery under general anaesthesia. 

 

OBJECTIVES

· To evaluate the duration of postoperative analgesia and requirement of analgesic doses during 24hours.

· To assess Ramsay sedation score.

· To assess intraoperative and postoperative haemodynamics.

· To find out duration of rescue analgesia.

· To detect Side effects/complication, if any.s

 

Inclusion Criteria:

· Patients willing to participate in the studys.

 Â· Patients of ASA Grade I and II of either gender.

· Patients undergoing elective midline neck surgeries under general anaesthesia

· Age of patients 18-65 years.

 

Exclusion Criteria:

 Â· Patient refusal.

 Â· Patient not nil by mouth.

· Patients with uncontrolled systemic disease like heart disease, liver disease, kidney disease.

 Â· Patients with anaemia, shock, septicaemia, uncontrolled hypertension.

· Patients with bleeding and coagulation disorders

· Infection at site Â· History of upper mediastinal irradication

· Inability to tolerate general anaesthesia

 Â· Any neck metastasis

 Â· History of previous head and neck surgery

 Â· Hoarse and weak voice

 

Methods:

This randomized clinical study will be conducted in Department of Anaesthesiology in Dhiraj hospital. After approval from institutional ethical committee a study will be conducted on 50 patients including both genders, aged between 18 to 65 years which will be equally divided randomly in 2 groups by chit method {Group A (0.25% Ropivacaine + Dexmedetomidine), Group B (0.25% ropivacaine + Dexamethasone)} for bilateral superficial cervical plexus block undergoing elective midline neck surgery under general anaesthesia will be selected. The drug will be administered by the anaesthesiologist not related to study. Group A (n=25) will receive 0.25% Ropivacaine 19ml + 50 mcg Dexmedetomidine 1 ml and Group B (n=25) will receive 0.25% Ropivacaine 19 ml + 4 mg Dexamethasone 1ml. All the patients will be explained clearly about the purpose and nature of the study in the language they can understand. They will be included in the study only after obtaining a written informed consent.

 

Study site: DHIRAJ HOSPITAL, S.B.K.S. MEDICAL INSTITUTE AND RESEARCH CENTER, SUMANDEEP VIDYAPEETH DEEMED TO BE UNIVERSITY, PIPARIA, VADODARA, GUJARAT.

 

Study design: randomized clinical study

 

LIKELY OUTCOME / BENEFITS OF THE STUDY:

This study will help us to know which drug out of two will be provide post operative analgesia more effectively and reduces the post operative intravenous analgesic use within 24 hours after midline neck surgery.

 
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