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

Effective Dose of Dexmedetomidine or Midazolam in Monitored Anesthesia Care for Patients Undergoing Ophthalmologic Surgery With Retrobulbar Nerve Block

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.

Study Overview

• Status: Unknown
• Conditions: Balanced Anesthesia; Adjuvants,Anesthesia
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Midazolam

Detailed Description

The allocation sequence is generated by computer random number generation, and the allocation is placed in sequentially numbered opaque sealed envelopes by a non-investigator. Enrolment and data collection are performed by trained research staff who are not involved in the care of the patients. The treating clinicians are not possible to be blinded to the assignment group, but all other staff involved in both the collection and collation of data, and administration of neurocognitive testing, are blinded to group allocation.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Recruiting
      • Eye, Ear, Nose and Throat Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients scheduled for ophthalmic surgery with retrobulbar nerve block

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dexmedetomidine; Dexmedetomidine will be used for perioperative sedation.	Drug: Dexmedetomidine; loading dose 0.5-2.5ug/kg followed by continuous infusion 0.2-0.5ug/kg/h
EXPERIMENTAL: Midazolam; Midazolam will be used for perioperative sedation.	Drug: Midazolam; loading dose 30-50ug/kg followed by continuous infusion 10-30ug/kg/h

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular pressure	Measured with Tono-Pen tonometer	Intraocular pressure will be measured at two time points: before sedative medication administration and before skin incision.
Bispectral index (BIS)	Anesthesia depth index	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)	Patient self-report pain score ranging from 0 to 10, with 0 defined as no pain at all and 10 as the intolerable pain.	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

Collaborators and Investigators

• Sponsor: Eye & ENT Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2019
• Primary Completion (ANTICIPATED): July 31, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: July 9, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (ACTUAL): July 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 1, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Midazolam; Monitored anesthesia care; Ophthalmic surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Dexmedetomidine
• Other Study ID Numbers: MAC in Eye Surgery

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No