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Clinical Trials/CTRI/2024/06/069611
CTRI/2024/06/069611
Not yet recruiting
Phase 4

Comparison of Laryngeal Mask Airway insertion score following Propofol-Ketamine vs Propofol-Fentanyl vs Propofol-Dexmedetomidine Anaesthesia in patients undergoing short surgical procedures.

Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, Rajnandgaon1 site in 1 country75 target enrollmentStarted: July 10, 2024Last updated:

Overview

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, Rajnandgaon
Enrollment
75
Locations
1
Primary Endpoint
LMA insertion score (In terms of mouth opening/jaw relaxation , ease of insertion and patient’s response such as swallowing, coughing/gagging, patient movement and laryngospasm).

Overview

Brief Summary

Study Title : Comparison of Laryngeal mask airway insertion score following Propofol-Ketamine vs Propofol-Fentanyl vs Propofol- Dexmedetomidine anaesthesia in patients undergoing short surgical procedures. 

Rationale: Insertion of laryngeal mask airway (LMA) requires sufficient depth of anesthesia for jaw muscles to relax and suppression of airway reflexes for the device to be tolerated within the hypopharynx without undue coughing, gagging, and patient movement. Such conditions are provided by a generous dose of an intravenous (IV) anesthetic induction agent. Propofol itself does not have analgesic activity and when used alone, the high doses required for induction may cause adverse cardiovascular effects.

In this study we are comparing three drug combinations namely Propofol-Ketamine, Propofol-Fentanyl , Propofol-Dexmedetomidine that which drug combination provides better LMA insertion conditions.

Aim: To compare the Laryngeal Mask Airway insertion score following Propofol-Ketamine vs  Propofol-Fentanyl  vs Propofol-Dexmedetomidine anaesthesia in patients undergoing Short Surgical Procedures.

    Objectives:

To compare the Laryngeal Mask Airway insertion conditions in terms of-

  1. mouth opening/jaw relaxation ,
  2. ease of insertion
  3. patient’s response such as swallowing, coughing/gagging,
  4. patient movement and
  5. laryngospasm

To compare the Hemodynamic changes following  anaesthesia  in all the three groups

Study Design : Prospective, randomized, interventional study Study Setting : Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College and Hospital, Rajnandgaon, Chhattisgarh Time Frame : July 2024 to September  2024 Study Approval : Institutional Scientific & Ethics Committee

Study Population  : Patients scheduled for elective surgeries at B.R.L.S.A.B.V.M. Medical College, Rajnandgaon

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients aged 18 to 60 years ASA I-II Patients undergoing elective short surgical procedures.

Exclusion Criteria

  • Patients refusal Hemodynamically unstable patients Mallampatti grade 3/4 History of OSA.

Outcomes

Primary Outcomes

LMA insertion score (In terms of mouth opening/jaw relaxation , ease of insertion and patient’s response such as swallowing, coughing/gagging, patient movement and laryngospasm).

Time Frame: LMA insertion score (In terms of mouth opening/jaw relaxation , ease of insertion and patient’s response such as swallowing, coughing/gagging, patient movement and laryngospasm) will be assessed at the time of LMA insertion( 30 seconds to 1 min after Propofol administration)

Secondary Outcomes

  • Systolic BP, Diastolic BP, Mean arterial BP, HR, RR , arterial oxygen saturation , ECG, End- tidal CO2(BP, HR, RR, SpO2, ETCO2, ECG noted at 1min, 3min, 5min, 7min, 10min and then every 5 min till the end of surgery.)

Investigators

Sponsor
Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, Rajnandgaon
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Varsha Sinha

Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, Rajnandgaon

Study Sites (1)

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