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临床试验/NCT03005665
NCT03005665已完成不适用

Effect of Orogastric Acetazolamide on Intraocular Pressure in Laparoscopic Donor Nephrectomies

Post Graduate Institute of Medical Education and Research, Chandigarh1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Change in Optic nerve sheath diameter being assessed

研究概览

简要总结

The purpose of the trial is to study the effect of acetazolamide administered via Ryle's tube on optic nerve sheath diameter in laparoscopic live donor nephrectomy patients.

详细描述

this study was done on 40 American Society of Anaesthesiologist(ASA) I & II live donors of either sex in adult age group undergoing laparoscopic live donor nephrectomy. After getting approval from institutes ethical committee and written informed consent, Donors were randomly allocated to either of two group. Anaesthesia was induced with injection morphine 0.1 mg/kg, injection propofol 1-2 mg/kg and vecuronium 0.1 mg/kg. Maintenance of anaesthesia was done with isoflurane and oxygen. After induction donors were placed into modified flank position with left side upward. Donors in Group A received Acetazolamide 5 mg/kg via orogastric tube soon after the induction of anaesthesia. Group S received saline as a placebo. investigator and subjects were blinded till the statistical analysis. Optic nerve sheath diameter was measured six times during perioperative periods by using high frequency ultrasound probe. Intra operative monitoring was done for Heart rate, Blood Pressure, pulse oximetry(Spo2), End Tidal Carbon Dioxide(ETCO2), Train Of Four(TOF) and Bi spectral index(BIS). Post operatively donors were reversed with injection neostigmine and glycopyrrolate.

once return of spontaneous ventilation was well established and patient becomes conscious oriented trachea was extubated and donors were shifted to post anaesthetic care unit(PACU). Postoperatively donors were monitored for Heart rate, Blood Pressure, Spo2, Comfort Score, Visual analog score for incisional site pain and shoulder tip pain, and Post operative nausea vomiting. Rescue analgesia was given to patients having comfort score less than 6.

After completion of study Optic nerve sheath diameter, pain scores and comfort scores was compared between both groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of either gender
  • 18-60 years of age
  • Hemodynamically stable patients.

排除标准

  • Patient's refusal.
  • Ocular Defects/ Wounds /Previous ocular surgery.
  • H/O Hypertension
  • Patients having Double Renal Arteries.
  • Laparoscopic Nephrectomies converted to Open Surgeries

研究组 & 干预措施

Group A - Acetazolamide

Experimental

Acetazolamide 5 mg/kg diluted in 10 ml normal saline through orogastric Ryle's Tube soon after the induction of anaesthesia followed by 10 ml normal saline flush.

干预措施: Acetazolamide (Drug)

Group s - Normal saline

Placebo Comparator

20 ml normal saline total volume.

干预措施: Normal Saline (Drug)

结局指标

主要结局

Change in Optic nerve sheath diameter being assessed

时间窗: baseline, 5 minutes, 10 minutes, 60 minutes, 120 minutes, 5 minutes post surgery

optic nerve sheath diameter measured during perioperative period

次要结局

  • Visual analog score for incision site and shoulder pain(baseline, 30 minutes, 60 minutes, 4 Hours, 12 hours, 24 Hours, 48 hours, 72 Hours.)

研究者

发起方
Post Graduate Institute of Medical Education and Research, Chandigarh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Ashish Singh Aditya

JUNIOR RESIDENT

Post Graduate Institute of Medical Education and Research, Chandigarh

研究点 (1)

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