Comparison of Nebulization with Dexmedetomidine versus Ketamine-Dexmedetomidine combination for Post-Operative Sore Throat in adult patients undergoing laparoscopic surgery - A Randomised parallel arm study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of Postopertive sore throat (POST) between both the groups.
研究概览
简要总结
Postoperative sore throat is a common complication following general endotracheal anaesthesia affecting patient’s postoperative comfort and satisfaction
Several pharmacological agents like Dexamethasone Ketamine Dexmedetomidine Magnesium sulphate etc have been tried through nebulization route have been studied with promising results Although Dexmedetomidine nubulisation and Dexmedetomidine in combination with Ketamine nebulisation are routinely used in Anaesthesiology practice there is literature deficit regarding there comparison for prevention of POST This study intends to compare efficacy of Dexmedetomidine nebulisation alone or Dexmedetomidine in combination with Ketamine nebulisation for prevention of POST in adult patients undergoing laparoscopic surgery
80 Patients will be randomized by computer generated randomization number into two groups D and DK with equal number of participants
Allocation concealment will be ensured through the use of sealed opaque envelopes
The patient and the investigator collecting the data will be blinded to the study intervention groups
The following baseline demographic and clinical characteristics will be recorded for all patients in preoperative area before shifting the patient to operating room age sex ASA physical status non invasive Blood Pressure Heart Rate SPO2 as baseline parameter Standard ASA provided NPO guideline will be followed for the study
All patients will undergo a thorough preoperative evaluation one day before surgery A detailed explanation of the study will be provided to each participant and written informed consent will be obtained Adequate fasting status will be confirmed before surgery and all patients will receive standard anti-aspiration prophylaxis
On the day of surgery Patients will be nebulized according to their assigned group as follows
Group D40 Patients will be nebulized with dexmedetomidine 1 mcg per kg diluted in 4 ml of normal saline over 15 minutes
Group DK40 Patients will be nebulized with a combination of dexmedetomidine 1mcg per kg and ketamine 0.5mg per kg diluted in 4 ml of normal saline over 15 minutes
In both groups standard anaesthesia management will be done as mentioned below
Upon arrival in the operating room standard American Society of Anesthesiologists ASA monitors will be attached including noninvasive blood pressure pulse oximetry electrocardiography
The patents will be preoxygenated with 100 percentage oxygen Induction will be achieved with intravenous fentanyl 1to2 mcg per kg and propofol 2mg per kg titrated to the effect of loss of verbal response and vecuronium 0.1 mg per kg and after securing airway with endotracheal intubation anaesthesia will be maintained with Isoflurane 0.5 to 1 MAC and O2 and N2O ratio is 40 and 60 ratio Smooth laryngoscopy and intubation lasted less than 15 sec will be performed by same well experienced anaesthesiologist to avoid interobserver bias
Normocapnia will be maintained with controlled mechanical ventilation with endtidal carbondioxide tension values ranging from 30 to 35 mmHg Euvolemia will be maintained with crystalloid infusion Normothermia will be maintained throughout the surgery with forced air warming device and infusion of warm fluids Antiemetic in the form of Ondansetron 4mg IV will be given 30 min before end of surgery Gentle extubation of the patient will be done after reversal of neuromuscular blocking agent after completion of the surgery
The following parameters will be recorded in the study CormackLehane grading during laryngoscopy ETT cuff pressure using a cuff manometer and hemodynamic parameters systolic diastolic and mean arterial pressures heart rate and oxygen saturation and sedation at predefined time points during induction laryngoscopy and intubation 1 and 5minutes postintubation and following pneumoperitoneum creation Airway pressure will be noted and keep less than 25 cm H2O after intubation and following intraabdominal gas insufflation The ETT intracuff pressure will be remeasured and documented just before extubation
In the postoperative period sore throat will be assessed and graded using 4 Point scale as per Harding and McVey at 10 minutes 6 hours 12 hours and 24 hours following extubation Sore throat will be treated according to standard POST treatment protocol Additionally hemodynamic parameters blood pressure heart rate and oxygen saturation will be recorded at extubation at 10 minute and 1 hour 6 hours 12 hours and 24 hours postextubation Sedation using Ramsay sedation score will be assessed at 15 minutes after nebulisation 10 minute 1 hour 6 hours after extubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with American Society of Anesthesiologist (ASA) physical status grading I & II.
排除标准
- •Non consenting patients.
- •Allergy to dexmedetomidine or ketamine.
- •3.Current upper respiratory tract infections, pre-existing sore throat and/or hoarseness.
- •4.Patients using steroids or nonsteroidal anti-inflammatory drugs.
- •5.Patients with chronic obstructive pulmonary disease, asthma.
- •6.Pregnant patients.
- •7.Any history of difficult intubation, loose teeth.
- •8.Difficult intubation requiring more than one attempt.
- •9.Already intubated patients.
- •10.Patients not extubated at the end of surgery.
- •11.Patients with sinus bradycardia, atrioventricular block, cardiac disease.
结局指标
主要结局
Incidence of Postopertive sore throat (POST) between both the groups.
时间窗: 10 mins,6hrs,12hrs and 24hrs after extubation.
次要结局
- To estimate and compare effect of nebulisation with dexmedetomidine and ketaminedexmedetomidine on heart rate (HR), systolic blood pressure (SBP), diastolic blood(pressure (DBP)and mean arterial pressure (MAP) at defined time point.)
- To estimate and compare effect of nebulisation with dexmedetomidine and ketamine-dexmedetomidine on patient sedation using Ramsay sedation score.(10 minutes,1hr,6hrs after extubation.)
研究者
Dr Nikhil Badetiya
All India Institute of Medical Sciences Bhopal
