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临床试验/CTRI/2024/09/073996
CTRI/2024/09/073996尚未招募4 期

Effects of intravenous magnesium suphate administration on postoperative analgesia in infraumbilical surgeries under spinal anaesthesia

Subhashree Jena1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年9月24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
To study effect of Intravenous Magnesium Sulphate administration on postoperative ananlgesia in infraumbilical surgeries under spinal anaesthesia

研究概览

简要总结

It is randomized and double blinded prospective study to evaluate the postoperative analgesic effect of Magnesium sulphate by perioperative administration via intravenous route and Intra-operative assessment of HR, BP, Spo2, RR, Input-Output was done. Postoperatively, the patients were assessed using VAS every 4 hours for 24hours. The Heart rate, Blood Pressure and MAP, Respiratory rate and SpO2 were also assessed every 4 hours for 24 hours. The secondary endpoints included assessment of the requirement of rescue analgesia and assessment of hemodynamic effects of magnesium administration in infraumbilical surgeries under spinal anaesthesia

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator 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 aged 18-65years, undergoing lower abdominal surgeries BMI 20-35 kg/m2 ASA Grade I and II Mallampati Score Class I and II Patients giving consent to be part of the study Hemodynamically Stable Patients Routine Investigations (CBC, RFT, LFT, SE)- within normal limits Duration of Surgery less than 4 hours.

排除标准

  • Patients unwilling to Consent Patients with ASA Grade III or IV Hemodynamical Instability (Hypotension, Bradycardia) Severe or Uncontrolled Diabetes or Hypertension, CVD Cardiovasular Disease (CAD, HF, Cardiomyopathies, Valvular Heart Diseases) Hepatic Impairment, Renal Impairment Known case of Coagulopathies, abnormal hemoglobin, Anaemia Known case of Kyphoscoliosis and deformity of spine.

结局指标

主要结局

To study effect of Intravenous Magnesium Sulphate administration on postoperative ananlgesia in infraumbilical surgeries under spinal anaesthesia

时间窗: After administration of the spinal anaesthesia, comparison between the two groups of onset and duration of sensory and motor blockade, duration of analgesia and time of rescue of analgesia will be assessed at baseline, after injection of study drug at immediate postop, 15mins, 30mins, 45mins, 60minms, 4hrs, 8hrs, 12hrs, 16hrs, 20hrs, 24hrs and assessment VAS score

次要结局

  • To study effect of Intravenous Magnesium Sulphate administration on postoperative ananlgesia in infraumbilical surgeries under spinal anaesthesia(Duration of analgesia will be assessed post surgery after administration of magnesium sulphate & time of rescue analgesia will be assessed)

研究者

发起方
Subhashree Jena
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Subhashree Jena

Dr D.Y. Patil Medical College, Hospital and Research Centre

研究点 (1)

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