跳至主要内容
临床试验/CTRI/2024/07/071709
CTRI/2024/07/071709尚未招募不适用

Sugammadex and neostigmine recovery indices in pediatric patients undergoing adenotonsillectomy-A prospective randomized study

VIRESH S KANNURE1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2024年8月12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
128
试验地点
1
主要终点
TO ASSESS THE POST OPERATIVE PARAMETER SUCH AS POST OP NAUSEA AND VOMITTING AFTER USING INJ.SUGAMMADEX

研究概览

简要总结

This the comparative study between two drugs such as sugammadex and neostigmine which are used for reversal agent of choice during general anaesthesia. The primary objective of the study is to compare the post-operative parameters (bradycardia, hypotension, hypertension, fever, dry mouth, respiratory depression, anaphylactic reaction.etc.) after using sugammadex and neostigmine as a reversal agent of choice.

Secondary objective is to compare the time required for extubation after using sugammadex and neostigmine + glycopyrrolate.

Sugammadex is a cyclodextrin based medicine used during general anesthesia to reverse the neuromuscular blocking effect of vecuronium as well as rocuronium. Its molecular structure comprises a modified γ-cyclodextrin core featuring hydrophilic outer surfaces and a lipophilic central cavity. This distinctive arrangement allows sugammadex to create complexes with the steroidal components of specific neuromuscular blockers.by doing so sugammadex does not act on acetylcholine receptors present on the neuromuscular junction and quickly reverse the neuromuscular blockage.

Neostigmine is a widely recognized and frequently utilized reversal agent during general anesthesia. It operates as an acetylcholinesterase inhibitor, effectively acting on non-depolarizing neuromuscular blocking agents. This action allows neostigmine to counteract the effects of these agents by inhibiting the breakdown of acetylcholine, thereby promoting increased muscle contraction and reversing neuromuscular blockade.

In this study we are giving sugammadex for one group of patients undergoing adenotonsillectomy and neostigmine for one group undergoing adenotonsillectomy they are randomized in two different groups by computer generated chit methods.

Both drugs are given at the end of surgery once the procedure is over and different parameters are noted. Sugammadex is given as 2 mg/kg dose and neostigmine is given as 0.05 mg/kg. Muscle relaxant of choice in the study is vecuronium as sugammadex only acts on vecuronium and rocuronium.

Inclusion criteria for study are – 1] Pediatric patient undergoing adenotonsillectomy, 2] Age group – 3-17 years, 3] ASA grade I and II.

Exclusion criteria for study are – 1] Any cardiovascular hepatic impairment. 2] Creatinine clearance <30 mg/ml.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
3.00 Year(s) 至 17.00 Year(s)(—)
性别
All

入选标准

  • 1] 3-17 AGE GROUP PATIENTS POSTED FOR ADENOIDECTOMY AND TONSILLECTOMY.
  • 2] ASA GRADE I AND II.

排除标准

  • 1] ANY CARDIOVASCULAR AND HEPATIC IMPAIRMENT.
  • 2] CREATININE CLEARANCE LESS THAN 30 MG/ML.
  • 3] ALLERGIC TO ANY ANESTHETIC AGENT.

结局指标

主要结局

TO ASSESS THE POST OPERATIVE PARAMETER SUCH AS POST OP NAUSEA AND VOMITTING AFTER USING INJ.SUGAMMADEX

时间窗: ASSESSMENT DONE IMMEDIETLY, AFTER 2 HRS AND AFTER 6 HRS OF EXTUBATION.

次要结局

  • TIME REQUIRED FOR EXTUBATION.(FROM CUTTING THE INHALATIONAL AGENTS AND GIVING INJ SUGAMMADEX AS REVERSAL TO EXTUBATION.)

研究者

发起方
VIRESH S KANNURE
申办方类型
Other [SELF ]
责任方
Principal Investigator
主要研究者

DR VIRESH SHRISHAIL KANNURE

BLDE DU,SHRI.B.M.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER,VIJAYPURA

研究点 (1)

Loading locations...

相似试验