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

NCT04018703 | Unknown

• 1 other identifier: MAC in Eye Surgery
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 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. 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. 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. 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.

Conditions

Balanced Anesthesia; Adjuvants,Anesthesia

Keywords

Monitored anesthesia care; Ophthalmic surgery; Dexmedetomidine; Midazolam

Outcome Measures

Primary Outcomes (2)

• Perioperative change of Observer's Assessment of Alertness/Sedation scale (OAA/S)

  Conventional subjective sedation scales with 1 to 5. Successful sedation was defined as an OAA/S scale score between 1 and 3, while failure was defined as an OAA/S score of more than 3.

  OAA/S score will be recorded from patient arrival in the operating room to about 30 minutes after surgery at following time points: before sedative administration, before skin incision, every 5 minutes intraoperatively and every 10 minutes in PACU.

• Numerical rating scale (NRS)

  The surgeons rated anesthesia management on a numerical rating scale (NRS), ranging from 0 to 10, with 10 defined as the best condition and 0 as the worst.

  Immediately after surgery, the surgeons report NRS only once

Secondary Outcomes (3)

• Intraocular pressure

  Intraocular pressure will be measured at two time points: before sedative medication administration and before skin incision.

• Bispectral index (BIS)

  Bis will be continuously recorded with BIS monitor from arrival in the operating room to discharge to ward (about 30 minutes after surgery).

• Visual analogue scale (VAS)

  VAS will be recorded at the following time points until 1h postoperatively: before sedative medication administration, before skin incision, every 10 minutes intraoperatively and 1h postoperatively

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Dexmedetomidine will be used for perioperative sedation.

Drug: Dexmedetomidine

Midazolam

EXPERIMENTAL

Midazolam will be used for perioperative sedation.

Drug: Midazolam

Interventions

Dexmedetomidine DRUG

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

Dexmedetomidine

Midazolam DRUG

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

Midazolam

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for ophthalmic surgery with retrobulbar nerve block

You may not qualify if:

• Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction. Patients with a preoperative history of mental disorder, hearing disorder, II-III degree atrioventricular block, known allergy or hypersensitivity to a2 receptor agonists and refusal of (or contraindications to) PNB. Patients with anticipated difficult airway.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Eye, Ear, Nose and Throat Hospital

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine; Midazolam

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Wenxian Li, M.D. Ph.D.

  Eye and ENT Hospital of Fudan University

  STUDY DIRECTOR

Central Study Contacts

Hui Qiao, M.D. Ph.D.

CONTACT

8615900598163; theyellow@163.com

Weihong Yang, M.D.

CONTACT

8618917785802; yangweihong@eentanesthesia.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Anesthesiologist

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 12, 2019
• Study Start: November 1, 2019
• Primary Completion: July 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)