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临床试验/CTRI/2025/07/092104
CTRI/2025/07/092104尚未招募2 期

Effect of intranasal Dexmedetomidine on optic nerve sheath diameter (ONSD) during suspension laryngoscopy in adult patients undergoing airway surgery: A randomised, placebo-controlled trial

AIIMS, New Delhi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Change in Optic nerve sheath diameter (measured via ultrasound)

研究概览

简要总结

This randomized, placebo-controlled trial aims to evaluate the effect of intranasal Dexmedetomidine on optic nerve sheath diameter (ONSD)—an indirect marker of intracranial pressure—during suspension laryngoscopy in adult patients undergoing elective airway surgery under general anesthesia.

Participants:

60 adults aged 18–60 years, classified as ASA I–III, scheduled for elective airway surgery, and who have provided informed consent. Exclusions include eye diseases, history of raised intracranial pressure, certain medications, severe systemic disease, pregnancy, and known allergy to Dexmedetomidine.

Design:

Participants will be randomly assigned to receive either intranasal Dexmedetomidine (1 mcg/kg) or normal saline spray 30 minutes before surgery. The trial is triple-blind—neither the patients, investigators, nor data analysts will know group assignments.

Outcomes:

Primary Outcome: Optic nerve sheath diameter (ONSD) at four key time points using ultrasound.

Secondary Outcomes: Blood pressure responses, sedation level, and cough response during extubation.

Analysis:

Statistical methods include t-tests, chi-square tests, and repeated measures ANOVA, with significance set at p<0.05.

Ethics & Timeline:

Ethical clearance and clinical trial registration will be obtained. The study will run over 18 months, with 12 months for recruitment and 6 months for follow-up and data analysis.

Expected Impact:

The study will help determine whether intranasal Dexmedetomidine effectively controls increases in intracranial pressure and cardiovascular responses during airway surgery, potentially improving anesthetic safety and patient comfort.

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 60.00 Year(s)(—)
性别
All

入选标准

  • Age: 18–60 years ASA physical status I ,II and III Scheduled for elective suspension laryngoscopy for airway surgery under GA Patient giving written informed consent.

排除标准

  • Eye diseases (Diabetic Retinopathy, Glaucoma, Retinal Detachment etc.) History of elevated ICP (pseudotumor cerebri, hydrocephalus, Ventriculo-peritoneal shunt) Known allergy to Dexmedetomidine Severe cardiovascular or neurological disease Pregnancy Patient taking a methyldopa / clonidine/ other alpha 2 agonist.

结局指标

主要结局

Change in Optic nerve sheath diameter (measured via ultrasound)

时间窗: T0- Pre-operative | T1- Pre-intubation (Post induction of anaesthesia) | T2- Just before removal of suspension laryngoscope | T3- pre-extubation

次要结局

  • Cough response(at extubation)
  • Level of sedation(Pre induction)
  • PRESSOR RESPONSE(Before induction (Baseline))

研究者

发起方
AIIMS, New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Rohit kumar

All india Institute of medical science,Ansari nagar East, New Delhi, 110029

研究点 (1)

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