Comparison of Laryngeal Mask Airway insertion score following Propofol-Ketamine vs Propofol-Fentanyl vs Propofol-Dexmedetomidine Anaesthesia in patients undergoing short surgical procedures.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
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-
- mouth opening/jaw relaxation ,
- ease of insertion
- patient’s response such as swallowing, coughing/gagging,
- patient movement and
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18 to 60 years ASA I-II Patients undergoing elective short surgical procedures.
排除标准
- •Patients refusal Hemodynamically unstable patients Mallampatti grade 3/4 History of OSA.
结局指标
主要结局
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).
时间窗: 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)
次要结局
- 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.)
研究者
Dr Varsha Sinha
Bharat Ratna Late Shri Atal Bihari Vajpayee Memorial Medical College, Rajnandgaon