跳至主要内容
临床试验/CTRI/2025/07/090479
CTRI/2025/07/090479尚未招募Phase 3 4

A Randomized Controlled Trial To Compare Application Of Betamethasone Gel And Lignocaine Gel On Endotracheal Tube To Reduce Post Operative Sore Throat, Cough And Hoarseness Of Voice In Laparoscopic Surgeries

Shree Krishna Hospital1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2025年7月22日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
入组人数
82
试验地点
1
主要终点
To compare the incidence of Post-Operative Sore Throat in betamethasone gel and lignocaine jelly, applied topically over the tracheal tube

研究概览

简要总结

After obtaining institutional ethics committee approval and written and informed consent from patients of ASA I to III who will be undergoing surgery under general anaesthesia with endotracheal intubation will be included in this study. Preanesthetic check-up will be carried out in all patients. The patients will be divided into two groups. In Group B—where patients were intubated with endotracheal tube lubricated with 0.05% betamethasone gel; group L—endotracheal tube lubricated with 2% lidocaine jelly. Patients will be kept Nil by mouth (NBM) for 8 hours for solids and 2 hrs for clear liquid before surgery with required medication before surgery Appropriate fluids will be started in preoperative room and will be continued in the operation theatre (OT). After the patient is taken in the operating room, monitors like Pulse oximetry, electrocardiogram, non-invasive blood pressure monitoring, manual blood pressure monitoring and end tidal carbon dioxide monitoring device will be applied and hemodynamic variables will be measured on arrival to the OT and every 5 min thereafter till the end of surgery. Standard anaesthesia technique for induction of general anaesthesia will be used. Patients will be premedicated with injection midazolam 0.02 mg/kg, fentanyl 2 mcg/kg, Lignocaine 2 % (preservative free) 1.5 mg/kg as per protocol. Patients will be induced with IV induction agents and with muscle relaxation as per the case. General anaesthesia will be given by Endotracheal Tube. Before intubation, the endotracheal tube was lubricated from the distal end of the cuff to a distance of 15 cm from the tip using 2.5 ml of 0.05% betamethasone dipropionate gel for patients in group B and with 2.5 ml 2% lidocaine jelly for patients in group L. Immediately after intubation and confirmation of the tube position, the tracheal tube cuff was inflated with room air to keep the intracuff pressure between 18 and 25 mmHg, measured using a tracheal cuff pressure manometer  Anaesthesia will be maintained by O2, AIR and Sevoflurane/ Desflurane. End-tidal CO2 will be maintained between 35 and 40 mm of Hg. Pulse rate, electrocardiogram, NIBP, and oxygen saturation will be monitored continuously throughout the procedure. Before extubation as per the standard protocol adequate anti emetic & analgesic will be given at the end of procedure. Inhale anaesthetic gas will be discontinued. After achieving spontaneous respiration efforts, neuromuscular blockade will be reversed with Inj. Neostigmine 0.05 mg/kg and Inj. Glycopyrrolate 0.01 mg/kg & patient will be extubated. During this process of extubation patient’s responses will be noted. After extubation, patients will be shifted to recovery room for further observation. Post operative period will be defined from time of extubation till 24 hours. The time of tracheal extubation will be noted and assessment of the patients for the incidence and severity of POST, HOV and PEC will be done at 1, 6, 12 and 24 h after extubation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator 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

  • ASA(American Society of Anaesthesiologists) physical status I,II,III Patients able to provide informed consent Patients with a normal airway anatomy Patients not taking medications that may interact with betamethasone or lidocaine.

排除标准

  • Patient who will not give consent More than two attempts at intubation Patients with URTI Patients with a predicted difficult airway Patients on steroid therapy.

结局指标

主要结局

To compare the incidence of Post-Operative Sore Throat in betamethasone gel and lignocaine jelly, applied topically over the tracheal tube

时间窗: Post-Operative Sore Throat

次要结局

  • Incidence and severity of Cough post extubation(Immediate post extubation)
  • Incidence and severity of hoarseness of voice(At 1,6,12,24 hrs after extubation)
  • Incidence and severity of postoperative sore throat(At 1,6,12,24 hours after extubation)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Nirali Panchal

Pramukh Swami Medical College,Bhaikaka University

研究点 (1)

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