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The Study of Different Sedative Medications in Monitored Anesthesia Care During Eye Surgery With Local Anesthesia

NCT04018703 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-11-03

No results posted yet for this study

Summary

Due to the delicacy and long duration of the procedure, ophthalmic surgery put forward higher requirements to anesthesia management:

1. The patient with local anesthesia without sedation is in a state of awareness, which will cause intense stress resulting in increased blood pressure, heart rate, muscle tension and even sense of pain;
2. Traction of extraocular muscles and eyeballs can induce oculocardiac reflex, followed by bradycardia, atrial or ventricular arrhythmia, conduction block, and even more worsen, life-threatening cardiac arrest may occur;
3. With the increase in average life expectancy and the improvement of quality of life requirements, the number of elderly patients in ophthalmic surgery is also increasing. These elderly patients are often combined with hypertension, diabetes, etc. and decreased tolerance of with general anesthesia;
4. For some retinal detachment surgery with difficulty in resetting, the patients will be required to change to the prone position immediately after surgery to improve the success rate of resetting. Conventional general anesthesia management are cumbersome and costly, which may not be likely to achieve the swift emergence.

Nowadays, monitoring Anesthesia Care (MAC) has developed into a flexible and unique anesthesia technology combining intravenous anesthesia with regional block anesthesia. MAC provides reasonable balance between economy, comfort and safety, efficiency by continuous monitoring of changes in respiratory and circulatory system, during process of sedation and analgesia. Airway management will be another issue as surgeons operate on the side of head and face. Studies have shown that MAC can achieve adequate sedation and analgesia to decrease blood pressure, provide acceptable surgical fields and reduce adverse reactions such as perioperative stress, pain and anxiety. Meanwhile, MAC make patients comfortable enough to cooperate with the surgeons, easy to be awakened with relatively short operation duration and improvement of perioperative safety.

Conditions

  • Balanced Anesthesia
  • Adjuvants,Anesthesia

Interventions

DRUG

Dexmedetomidine

loading dose 0.5-2.5ug/kg followed by continuous infusion 0.2-0.5ug/kg/h

DRUG

Midazolam

loading dose 30-50ug/kg followed by continuous infusion 10-30ug/kg/h

Sponsors & Collaborators

  • Eye & ENT Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Wenxian Li, M.D. Ph.D. · Eye and ENT Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2021-07-31
Completion
2021-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04018703 on ClinicalTrials.gov