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CTRI Number  CTRI/2021/05/033423 [Registered on: 06/05/2021] Trial Registered Prospectively
Last Modified On: 03/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   CHANGES IN MALLAMPATI GRADING IN UROLOGICAL PROCEDURES DONE IN LITHOTOMY AND PRONE POSITIONS 
Scientific Title of Study   EVALUATION OF CHANGES IN MALLAMPATI GRADING IN PATIENTS UNDERGOING ELECTIVE UROLOGICAL PROCEDURES IN LITHOTOMY AND PRONE POSITIONS A PROSPECTIVE OBSERVATIONAL STUDY 
Trial Acronym  MPG 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  CHAGANTI SHARMILA 
Designation  POST GRADUATE STUDENT 
Affiliation  NIZAMS INSTITUTE OF MEDICAL SCIENCES 
Address  DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE NIZAMS INSTITUTE OF MEDICAL SCIENCES PANJAGUTTA HYDERABAD TELANGANA

Hyderabad
TELANGANA
500082
India 
Phone  8106177998  
Fax    
Email  sharmila.chaganti@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR NIRMALA JONNAVITHULA 
Designation  PROFESSOR 
Affiliation  NIZAMS INSTITUTE OF MEDICAL SCIENCES 
Address  DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE NIZAMS INSTITUTE OF MEDICAL SCIENCES PANJAGUTTA HYDERABAD TELANGANA

Hyderabad
TELANGANA
500082
India 
Phone  9849422749  
Fax    
Email  njonnavithula@gmail.com  
 
Details of Contact Person
Public Query
 
Name  CHAGANTI SHARMILA 
Designation  POST GRADUATE STUDENT 
Affiliation  NIZAMS INSTITUTE OF MEDICAL SCIENCES 
Address  DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE NIZAMS INSTITUTE OF MEDICAL SCIENCES PANJAGUTTA HYDERABAD TELANGANA

Hyderabad
TELANGANA
500082
India 
Phone  8106177998  
Fax    
Email  sharmila.chaganti@gmail.com  
 
Source of Monetary or Material Support  
DEPT OF ANAESTHESIOLOGY AND INTENSIVE CARE NIZAMS INSTITUTE OF MEDICAL SCIENCES PANJAGUTTA HYDERABAD TELANGANA 
 
Primary Sponsor  
Name  NIZAMS INSTITUTE OF MEDICAL SCIENCES 
Address  NIZAMS INSTITUTE OF MEDICAL SCIENCES PANJAGUTTA HYDERABAD TELANGANA 500082 
Type of Sponsor  Government 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 
CHAGANTI SHARMILA  NIZAMS INSTITUTE OF MEDICAL SCIENCES  DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE NIZAMS INSTITUTE OF MEDICAL SCIENCES PANJAGUTTA HYDERABAD TELANGANA 500082
Hyderabad
TELANGANA 
8106177998

sharmila.chaganti@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: N202||Calculus of kidney with calculus of ureter,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA Grade I II
Age 18 to 60
MPG grade I II III
Any gender
Patients undergoing elective urological surgeries URSL TURBT PCNL
Patients willing to participate
 
 
ExclusionCriteria 
Details  Patient refusal
Anticipated difficult airway difficult mask ventilation difficult intubation
MPG grade IV
Inability to open mouth for assessment
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the changes in mallampati grading in patients undergoing elective urological procedures in lithotomy URSL TURBT and prone PCNL positions under general anaesthesia
and the time required to revert to the preoperative state  
Mallamapti grade is assessed preoperatively and postoperatively at 4hrs, 8hrs, 12hrs, 24hrs, 48hrs, 72hrs, 96hrs and the study is discontinued when mallampati grade reverts to the preoperative state 
 
Secondary Outcome  
Outcome  TimePoints 
To find out any relation b/w the volume of intraoperative i.v fluids and irrigation fluids used and
Duration of surgery for the PCNL,URSL, TURBT surgery for aggravating airway edema 
postoperatively at 4hrs, 8hrs, 12hrs, 24hrs, 48hrs,96hrs.  
 
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   N/A 
Date of First Enrollment (India)   10/05/2021 
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
Modification(s)  
1.M. Boutonnet, V. Faitot, A. Katz, L. Salomon, H. Keita, Mallampati class changes during pregnancy, labour, and after delivery: can these be predicted? Br. J.Anaesth. 104 (1) (2010 Jan) 67e70 2.E. Teo, B. S Kelley, I. Black, Observational Study of Mallampati Changes After Prone Spinal Surgery, 2014(26)606-610 3.S. Padhy, N.Jonnavithula, G.Ramachandran, Evaluation of changes in mallampati class in patients undergoing percutaneous nephrolithotomy surgeries in the prone position: A prospective observational study, Trends in Anaesthesia and Critical Care (2018 July)1e5. 4.B.S. Kodali, S. Chandrasekhar, L.N. Bulich, G.P. Topulos, S. Datta, Airway changes during labour and delivery, Anesthesiology 108 (3) (2008 Mar)357e362. 5.S. Pilkington, F. Carli, M.J. Dakin, M. Romney, K.A. De Witt, C.J. Dore, et al., Increase in Mallampati score during pregnancy, Br. J. Anaesth. 74 (6) (1995 Jun) 638e642.  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

After ethics approval subjects will be recruited into the study after informed and written consent, prospective observational study will be done in patients undergoing elective PCNL(prone) and URSL, TURBT(lithotomy) surgeries under general anesthesia requiring oral endotracheal tube. Each group has 30 patients each

Preoperative:

Thorough history about patients past and present illness will be taken along with general and systemic examinations being done. Routine investigations will be done. Height, weight and nutritional status of the patient are noted. Airway assessment will be done using mallampati grading with patient in sitting position head neutral mouth open as wide as possible and maximal tongue protrusion without phonation along with other airway parameters like thyromental distance, sternomental distance,inter incisor distance, neck circumferences.

Intraoperative:

Patients will be shifted to the OT after fasting status is confirmed. All the ASA standard monitors connected. IV lines secured. Patient is preoxygenated with 100% oxygen for 3 minutes. Premedicated with glycopyrrolate and Fentanyl 1-2 mcg/kg. Patient induced with propofol 1-2mg/kg and sevoflurane 2%. After the ability to ventilate is confirmed, relaxant atracurium is given 0.5 mg/kg. Bag mask ventilation is done for 3mins. Tracheal intubation is done with appropriate oral endotracheal tube bilateral air entry confirmed and fixed and connected to mechanical ventilation. Number of attempts for intubation, use of bougie(if any) and duration of intubation is noted. Anaesthesia is maintained on sevoflurane 2% ,Oxygen , Air, and intermittent relaxant boluses. Appropriate analgesia is given. Duration of surgery, amount of intraoperative fluids given, amount of irrigating fluids used are noted. Post procedure patients are  reversed of neuromuscular blockade  with neostigmine 50mcg/kg and glycopyrrolate 10mcg/kg. After assessing the patient’s spontaneous breath attempts and attaining adequate muscle power trachea is extubated.

Postoperative:

Patient is followed up postoperatively at 4hrs, 8hrs, 12hrs,24hrs, 48hrs, 72hrs, intervals and the MPG grade is noted in sitting position without phonation with maximal mouth opening and tongue protrusion with head in neutral position and any changes are noted. If any change is noted the patient is followed up it is reverted back to normal and the duration for it is noted. The study is discontinued after the MPG grade reverts to the preoperative grade. The MPG grade is evaluated by a resident not involved in the study.               


 
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