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临床试验/CTRI/2024/06/068399
CTRI/2024/06/068399尚未招募4 期

Comparison of Effect of Neostigmine And Sugammadex On Post Operative Diaphragmatic Function assessed Ultrasonographically in Adult Patients Undergoing Oro-Maxillofacial Surgery: A Randomized Control Trial

All India Institute of Medical Sciences Jodhpur1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月10日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Comparison of the change in diaphragmatic excursion at baseline and after TOFR more than 0.9 with Neostigmine and Sugammadex as reversal agents for neuromuscular blockade.

研究概览

简要总结

Neuromuscular blocking agents are frequently administered in surgical settings. Ensuring effective reversal of neuromuscular blockade is crucial for the restoration of muscle function to its preoperative state, thus safeguarding patients against postoperative pulmonary complications. 

Patients will be randomly assigned with a 1:1 ratio to the Neostigmine (A group) and Sugammadex (B group). Preoperative assessment will be conducted in the preoperative area, one hour before surgery, using Ultrasound (GE Healthcare).  Diaphragmatic excursion and thickness fraction – indicative of inspiratory and expiratory muscle strength, will be measured while the patient is in a semi-recumbent position, with the head of the bed elevated to 45 degrees. The diaphragmatic excursion is evaluated through ultrasonography by placing the probe on the midclavicular line along the costal margin, angled over 70 degrees targeting the diaphragm dome (probe directed medially, cephalad, and dorsally) and then initiating M-mode tracing. Diaphragmatic excursion (DE) is the vertical thickness from the baseline to the highest inspiration point in quiet breathing. Diaphragm thickness is measured using a high frequency 10 MHz linear probe- B mode. Diaphragmatic Thickness fraction = Te insp - Te exp/ Te exp, where Te insp and Te exp are the thickness at the end of inspiration and expiration respectively. Internal oblique muscle thickness refers to the expiratory muscle strength. A linear probe will be placed midway between the costal margin and the iliac crest in the anterior axillary line with the probe perpendicular to the abdominal wall. Internal oblique muscle thickness is also measured at the end inspiration and also when the patient coughs with maximum strength.1

TFIO =end coughing thickness-end inspiratory thickness / end inspiratory thickness X 100

All the above parameters will be measured 3 times each and the mean value will be considered   for data analysis.

In the operation theatre, the patients will be monitored with a three-lead ECG, NIBP, and pulse oximetry. A standard Anaesthesia protocol for induction will be followed in all patients. After 3 minutes of preoxygenation with 100% oxygen, general anaesthesia will be induced with Fentanyl 2 mcg/kg , Propofol 2–3mg/kg, and Rocuronium 0.6-1.2 mg /kg. Maintenance with inhalation agent- Sevoflurane, maintaining a MAC of 1. Neuromuscular transmission monitoring (NMT) will be done in all patients to look for train of four (TOF).

Reversal agent- either Neostigmine 50 mcg/kg or Sugammadex 4 mg/kg will be given when TOFR is 0.7. The patient will be assessed in the immediate post extubation period and 30 minutes post extubation in PACU, using ultrasonography in the same technique to measure diaphragmatic excursion, diaphragmatic thickness fraction and internal oblique thickness fraction. Both the preoperative and postoperative values will be compared and analysed for any residual effect of the neuromuscular blockade.

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

  • Adults (18-65 years) undergoing elective oro-maxillofacial surgeries under general anaesthesia, receiving neuromuscular blockade.

排除标准

  • 1.Patients denying consent to participate in the study.
  • 2.Patients with lung disease- COPD, ILD.
  • 3.Any condition in which diaphragm cannot be assessed using ultrasonography.
  • 4.Patients with diaphragmatic hernia, ascites, stroke, pregnancy 5.Patients with suspected neuromuscular disease/ phrenic nerve injury.
  • 6.Patients who require postoperative mechanical ventilation.
  • 7.Patients with any contraindications or known allergy to Neostigmine or Sugammadex.

结局指标

主要结局

Comparison of the change in diaphragmatic excursion at baseline and after TOFR more than 0.9 with Neostigmine and Sugammadex as reversal agents for neuromuscular blockade.

时间窗: At baseline and at TOFR more than 0.9

次要结局

  • Comparison of the change in internal oblique thickness fraction at baseline and after TOFR more than 0.9 with Neostigmine and Sugammadex as reversal agents for neuromuscular blockade.
  • Comparison of the change in diaphragmatic thickness fraction at baseline and after TOFR more than 0.9 with Neostigmine and Sugammadex as reversal agents for neuromuscular blockade.
  • Comparison of the change in diaphragmatic excursion at baseline and after 30 minutes in PACU with Neostigmine and Sugammadex as reversal agents for neuromuscular blockade.(At baseline and after 30 minutes in PACU)
  • Comparison of the change in diaphragmatic thickness fraction at baseline and after 30 minutes in PACU with Neostigmine and Sugammadex as reversal agents for neuromuscular blockade.
  • Comparison of the change in internal oblique muscle thickness fraction at baseline and after 30 minutes in PACU with Neostigmine and Sugammadex as reversal agents for neuromuscular blockade.(At baseline and after 30 minutes in PACU)
  • Time taken to achieve a TOFR more than 0.9 after injecting Neostigmine and Sugammadex.
  • Any side effects of Neostigmine and Sugammadex.

研究者

发起方
All India Institute of Medical Sciences Jodhpur
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Swati Chhabra

All India Institute of Medical Sciences Jodhpur

研究点 (1)

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