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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
, (1) ICD-10 Condition: N202||Calculus of kidney with calculus of ureter, |
|
Intervention / Comparator Agent
|
|
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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