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临床试验/CTRI/2023/10/058610
CTRI/2023/10/058610尚未招募不适用

Comparison of STOP-BANG and BERLIN questionnaire in the prediction of overweight and obese patients developing desaturation during induction of general anaesthesia

JSS Academy of Higher Education and Researcg1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年10月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To record the onset of desaturation & time taken to reach oxygen saturation of 93% on room air.

研究概览

简要总结

Following approval from the Institutional Ethical Committee, informed consent will be taken from 100 patients satisfying the inclusion criteria will be allocated by Randomization using shuffled Sealed Envelope Technique. Patients will be allotted into 2 groups namely Group 1 (assessed by the Berlin Questionnaire) and Group 2 (assessed by the STOP-BANG Questionnaire).

Total number of patients 100, with 50 patients in each group.

  1. Group 1 (n=50) : screened by the Berlin Questionnaire

  2. Group 2 (n=50) : screened by the STOP-BANG Questionnaire

All patients will be admitted before the surgery and pre anaesthetic evaluation will be done. Fasting of 6 hours for solids and 2 hours for clear liquids will be ensured.

After obtaining written informed consent, patients between the ages of 18 years up to the age of 60 years belonging to ASA grade of I–II of either gender, with BMI greater than or equal to 25 posted for elective surgery under general endotracheal anaesthesia will be included in the study. Patients less than the age of 18 years or greater than 60 years, belonging to ASA grades III and above, having BMI less than 25, undergoing emergency surgeries, with contraindications to any of the general anaesthetics or muscle relaxants (such as succinylcholine), allergy to anaesthetics, already diagnosed cases of OSA who are on treatment (such as CPAP) will be excluded from the study.

On the day of surgery Intravenous (IV) access will be secured. In the operation theatre standard monitoring devices will be attached, including noninvasive arterial blood pressure, ECG and peripheral oxygen saturation probe using the GE Medical Systems Information Technologies, Inc. B125M Patient Monitor. Baseline readings will be recorded.

With the patient in supine position, patients will be appropriately premedicated with premedicants Inj. Ondansetron (4mg), Inj. Midazolam (1mg), Inj. Glycopyrrolate (0.2mg) and Inj. Fentanyl (1mcg/kg body wt). Patients from both the groups will be preoxygenated for three minutes with 100% oxygen, using closed circuit keeping total fresh gas flow at 10 litres. After this, patients will be administered 1.5mg/kg/body weight of IV lidocaine (preservative free), followed by induction with 1% Propofol 2 mg/kg, till there is loss of eye lash reflexes.

After trial ventilation and assessing for demonstrable bag and mask ventilation, depolarising muscle relaxant Inj. Succinylcholine 1.5 mg/Kg is administered for facilitating laryngoscopy & intubation. If bag and mask ventilation was difficult, patients were excluded from the study. Upon induction bag and mask ventilation is withdrawn briefly. Airway is maintained by triple manoeuvre (Head tilt, chin lift and jaw thrust).

Thereafter, the investigator will assess and record the time taken for the oxygen saturation to reach upto 93%. Intraoperative and postoperative desaturation events and other airway complications will also be observed and documented. (SpO2 cut-off: upto 93% in Room Air via peripheral oxygen saturation i.e., pulse oximetry).

The parameters assessed will be -

  1. Desaturation onset time : Desaturation onset time will be considered after induction (loss of eyelash reflex) as the time taken from the administration of Succinylcholine till the first sign of fall in saturation from maximum saturation.

  2. Period of desaturation : Period of desaturation will be considered after induction (loss of eyelash reflex) and administration of succinylcholine as the time taken for the saturation to drop to 93% on RA from the desaturation onset time.

  3. Difficult Airway Events : Difficulty airway events including use of advanced airway, number of intubation attempts, need for reintubation after extubation and airway trauma.

Bag and mask ventilation will be resumed immediately followed by endotracheal intubation with mechanical ventilation. The peripheral oxygen saturation will be recorded heart rate and arterial pressure will be recorded at 0 and then at 3min intervals for the first 15 mins and then every 10 mins till end of surgery.

Hypotension (20% or more decrease in mean arterial blood pressure [MAP] from the baseline value) will be treated with boluses of IV Mephentermine (6 mg) and crystalloid infusion until the normotensive state is achieved. Bradycardia (20% or more decrease in heart rate [HR] from the baseline value) will be treated with 0.6 mg IV atropine.

On extubation, patient will be observed for any desaturation (SpO2 less than 92% on Room Air). Patient will be observed for any desaturation and will be managed with O2 mask and or side effects such as nausea and vomiting in the post operative period.

研究设计

研究类型
Observational

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 between the ages of 18 years and 60 years 2) ASA grade I-II of either gender 3) BMI greater than or equal to 25 4) Posted for elective surgery under general endotracheal anaesthesia 5) Informed consent given.

排除标准

  • •Patients undergoing emergency surgeries.
  • •Contraindications to any of the general anaesthetics or muscle relaxants (such as succinylcholine).
  • •Allergy to anaesthetics.
  • •Already diagnosed cases of OSA who are on treatment (such as CPAP).
  • •Diagnosed cases of COPD.
  • •Diagnosed cases of severe cardiac disease.
  • •Patients with scoliosis.
  • •Patients with restrictive lung disease.
  • •Patient refusal for the procedure.

结局指标

主要结局

To record the onset of desaturation & time taken to reach oxygen saturation of 93% on room air.

时间窗: After induction (loss of eyelash reflex) as the time taken from the administration of succinylcholine till the first sign of fall in saturation upto 93% on room air within the first one minute.

次要结局

  • To assess airway complications associated with overweight & obese patients undergoing general endotracheal anaesthesia(From the time of induction of general anaesthesia upto two hours in the post-operative period.)

研究者

发起方
JSS Academy of Higher Education and Researcg
申办方类型
Private medical college

研究点 (1)

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