FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/01/022597 [Registered on: 02/01/2020] Trial Registered Prospectively
Last Modified On: 16/12/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Preventive 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Dexmedetomidine injection for pain relief after renal stone surgery 
Scientific Title of Study   To evaluate the role of intramuscular dexmedetomidine in alleviatung catheter related bladder symptoms and postoperative inflammatory response following percutaneous nephrolithotomy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Not in any registry  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nirmala Jonnavithula 
Designation  Professor 
Affiliation  Nizams Institute of Medical Sciences 
Address  Dept. of Anaesthesiology and Intensive care Speciality block, 3rd floor NIMS Panjagutta

Rangareddi
ANDHRA PRADESH
500082
India 
Phone  9849422749  
Fax    
Email  njonnavithula@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nirmala Jonnavithula 
Designation  Professor 
Affiliation  Nizams Institute of Medical Sciences 
Address  Dept. or Anaesthesiology and intensive care Speciality block 3rd floor NIMS Panjagutta

Rangareddi
ANDHRA PRADESH
500082
India 
Phone  9849422749  
Fax    
Email  njonnavithula@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nirmala Jonnavithula 
Designation  Professor 
Affiliation  Nizams Institute of Medical Sciences 
Address  Dept. of Anaesthesiology and Intensive care Speciality block 3rd floor NIMS Panjagutta

Rangareddi
ANDHRA PRADESH
500082
India 
Phone  9849422749  
Fax    
Email  njonnavithula@gmail.com  
 
Source of Monetary or Material Support  
Nizams institute of medical sciences 
 
Primary Sponsor  
Name  Nizams institute of medical sciences 
Address  Dept. of Anaesthesiology and intensice care, Panjagutta Hyderabad Telangana 500028 India 
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 Nirmala Jonnavithula  Nizams institute of medical sciences, Panjagutta, Hyderabad  Urology operation theatre Dept. of urology Specialty block 3rd floor
Rangareddi
ANDHRA PRADESH 
9849422749

njonnavithula@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMS INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , , (1) ICD-10 Condition: N20||Calculus of kidney and ureter,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intramuscular injection of dexmedetomidine  Single dose of 1 microgram/kg intramuscular dexmedetomidine 
Comparator Agent  normal saline  Single dose of equal volume of Intramuscular normal saline 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Inclusion criteria: Patients scheduled for elective PCNL procedures, ASA grade 1&2 and age 18-60 years
 
 
ExclusionCriteria 
Details  pregnancy, renal failure, patients on analgesics, rate controlled drugs, seizure disorders, patient on antidepressants / antipsychotics, unwillingness to give consent.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the role of IM dexmedetomidine in alleviating the catheter related bladder
symptoms based on visual analogue pain scale.
To evaluate the inflammatory response as evidenced by fever, tachycardia, total WBC count, ESR
 

intubation response at 1,5,10 mim and immediately after extubation.
CRBS and inflammatory responseon day 0. 1,2 and 3 
 
Secondary Outcome  
Outcome  TimePoints 
Intubation response
Sedation score by Ramsay sedation scale
Adverse effect like bradycardia and hypotension:

 
Base line
Before IM inj

30 min after IM Inj

1 min after Intubation
5 min
10 min
After extubation
 
 
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 1/ Phase 2 
Date of First Enrollment (India)   02/01/2020 
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="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   published once it is completed 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Catheter-related bladder discomfort (CRBD) has gained its recognition as a problem in the early postoperative period causing significant distress to the patient.  The incidence of CRBD is about 60% ranging from 47% to 90%.1 The patient frequently complaints of lower abdominal pain with an intense urge to micturate. Symptoms of CRBD mimic those of an overactive bladder (OAB). It is usually accompanied by behavioral responses, such as flailing limbs, strong vocal response, and attempting to pull out the urinary catheter which in turn can lead to increase in postoperative pain requiring attention to postoperative analgesia and also prolonged hospital stay. Therefore, targeting this discomfort at the earliest is mandatory.

CRBD manifests itself by spontaneous contractions in the detrusor muscle due to physical stimulation of the catheter.2,3 The site of origin of the discomfort and dysuria is not clear and could be from any of the following - the renal pelvis, ureter, urinary bladder or the urethra.

Various medications, like antimuscarinic agents, antiepileptic agents, analgesics, and narcotics, have been used to treat CRBD with varied results. So search for the ideal agent continues. Dexmedetomidine, an α-2 receptor agonist, which has a good sedative, analgesic, and anxiolytic properties has also shown to have antimuscarinic activity (M3 receptor) in animal studies.4 It is this potential of dexmedetomidine to reduce the spontaneous bladder contraction via M3 muscarinic receptor antagonism and also by its α-2 receptor agonism, enabled 5 us to further explore its potential benefit in alleviating the incidence and severity of CRBD. We, therefore, evaluated the efficacy of dexmedetomidine in reducing the incidence and severity of CRBD. 

Dexmedetomidine in addition its tremendous therapeutic benefits; also has a reversal agent atipamezole which renders dexmedetomidine near ideal for perioperative use. But the dexmedetomidine- an α induced bradycardia or hypotension has recently attracted considerable attention because of its potentially grave consequences, including sinus arrest and refractory cardiogenic shock. A route other than intravenous injection or a low dose may help minimize cardiovascular risks associated with dexmedetomidine  Intramuscular (IM) dexmedetomidine could be a promising alternative by minimizing its cardiovascular risks and preserving respiratory function.

We hypothesized that the antimuscarinic effect of dexmedetomidine  may reduce the CRBD and conducted this prospective study to investigate the clinical effects of low-dose of IM dexmedetomidine (1 μg·kg–1) on CRBD following percutaneous nephrolithotomy (PCNL) where the patient frequently suffers discomfort with CRBD rather the surgical site pain.

 

Aims:

The primary aim of the present study is

  To evaluate the role of IM dexmedetomidine in alleviating the catheter related bladder 

   symptoms based on visual analogue pain scale.

  To evaluate the inflammatory response as evidenced by fever, tachycardia, total WBC count, ESR

 

Secondary outcome:

  Intubation response

  Sedation score by Ramsay sedation scale

  Adverse effect like bradycardia and hypotension

Methodology:

 

This study protocol will initially be submitted to NIMS ethics committee for approval.

 

Sample Size: 60

Study Design: Prospective randomized double blind controlled study. They will be randomized in to two groups by computer generated random numbers and sealed envelop method. Group I will receive 1µg/kg of IM dexmedetomidine and group II will receive normal saline and will act as control group.

 

Study population; Both male and female patients scheduled for PCNL

Study period: 6 months

 

 

Sixty patients aged between 18-60 years scheduled for percutaneous nephrolithotomy who has consented for the study will be enrolled for the study. The following investigations will be done and will be noted in postoperative period for 3 days – haemoglobin, total count, blood urea, serum creatinine and erythrocyte sedimentation rate and temperature for the study.

The patients will be kept nil per oral as per the fasting guidelines. A thorough preanesthetic evaluation will be done one day before surgery. The following will be the inclusion and exclusion criteria.

Inclusion criteria:  Patients scheduled for elective PCNL procedures, ASA grade 1&2 and age 18-60 years

Exclusion criteria: Age <18 and >60 years, ASA- 3 or above, pregnancy, renal failure, patients on analgesics, rate controlled drugs, seizure disorders, patient on antidepressants / antipsychotics, unwillingness to give consent.

Post inclusion exclusion criteria:

Cases were excluded after inclusion if excess bleeding occurred during the procedure, surgical procedure extending more than 3 hours, delayed recovery, requiring postoperative ventilation, data acquisition is incomplete, and patient withdrawal  from the study

All the study participants will be informed about the study protocol and the drug its uses and complications. A written informed consent will then be taken and will be enrolled for the study. All the patients will be premedicated with tab ranitidine 150mg on the night before and also on the morning of the day of surgery. Sedative/ anxiolytic premedication will be avoided in view of the study drug. Once the patient is wheeled in to the theatre complex the baseline readings of heart rate, blood pressure( systolic, diastolic and mean), haemoglobin saturation, entropy and sedation score will be noted and then the study drug will be administered as per randomization either dexmedetomidine or normal 30 min before the induction of anesthesia. Patients will be anesthetized as per standard protocol. Inj thiopentone 4-5mg/kg, inj fentanyl 2µg/kg and will be intubated with appropriate size cuffed endotracheal tube facilitated with inj atracurium and Inj ondonsetron 4mg will be given at the time of induction. The following readings HR, blood pressure, Spo2, entropy and sedation score will be noted 30 min after study drug and once the intubation is done at 1min, 5, 10 min. Once the surgical procedure is done the duration of surgical procedure and the double J stent placement will be noted and peritubal infiltration of 0.25% bupivacaine will be given at 6 and 12o clock position with 25 G spinal needle under fluoroscopic guidance. All the patients will be given Inj paracetamol 1gram IV intraoperatively and the residual neuromuscular blockade will be reversed with inj glycopyrrolate and neostigmine and will be extubated once they meet the extubation criteria. Immediately after extubation the pain CRBS will be assessed with VAS scale for three days  and if the score is 3 or >3 rescue analgesia of IV paracetamol 1gram will be given every 8th hrly or till the pain score is 3. The postoperative investigations will be done for 3 days and the study ends here.

 The very purpose of this study is to find a way out for the immediate pain /irritation relief by a simple measure by giving IM dexmeditomidine before the procedure

References:

1.     Maghsoudi RFarhadi-Niaki SEtemadian M Kashi AHShadpour P Shirani ASamadinezhad-Khoshbaf-Sorkhabi RTabatabaei M. Comparing the efficacy of tolterodine and gabapentin versus placebo in catheter related bladder discomfort after percutaneous nephrolithotomy: A randomized clinical trial. J Endourol. 2018 Feb;32(2):168-174. doi: 10.1089/end.2017.0563. Epub 2018 Jan 26.

 

2.     Agarwal A, Yadav G, Gupta D, Singh PK, Singh U. Evaluation of intra-operative tramadol for prevention of catheter-related bladder discomfort: A prospective, randomized, double-blind study. Br J Anaesth 2008;101:506–510.

3.      Shariat Moharari R, Lajevardi M, Khajavi M, Najafi A, Shariat Moharari G, Etezadi F. Effects of intra-operative ketamine administration on postoperative catheter-related bladder discomfort: A double-blind clinical trial. Pain Pract 2014;14:146–150

4.     Hegde SS. Muscarinic receptors in bladder: From basic research to therapeutics. Br J Pharmacol 2006;147:80-7. 

Tapas Kumar SinghSandeep Sahu,  Anil Agarwal,  Devendra Gupta,  Prabhaker Mishra. Dexmedetomidine for prevention of early postoperative catheter-related bladder discomfort in voluntary kidney donors: Prospective, randomized, double-blind, placebo-controlled trial

 

 

 

 

 

 

 
Close