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出境医 / 临床实验 / The Study of Different Sedative Medications in Monitored Anesthesia Care During Eye Surgery With Local Anesthesia (MAC)

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

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Balanced Anesthesia Adjuvants,Anesthesia Drug: Dexmedetomidine Drug: Midazolam Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effective Dose of Dexmedetomidine or Midazolam in Monitored Anesthesia Care for Patients Undergoing Ophthalmologic Surgery With Retrobulbar Nerve Block
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
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

Outcome Measures
Primary Outcome Measures :
  1. Perioperative change of Observer's Assessment of Alertness/Sedation scale (OAA/S) [ Time Frame: 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. ]
    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.

  2. Numerical rating scale (NRS) [ Time Frame: Immediately after surgery, the surgeons report NRS only once ]
    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.


Secondary Outcome Measures :
  1. Intraocular pressure [ Time Frame: Intraocular pressure will be measured at two time points: before sedative medication administration and before skin incision. ]
    Measured with Tono-Pen tonometer

  2. Bispectral index (BIS) [ Time Frame: Bis will be continuously recorded with BIS monitor from arrival in the operating room to discharge to ward (about 30 minutes after surgery). ]
    Anesthesia depth index

  3. Visual analogue scale (VAS) [ Time Frame: 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 ]
    Patient self-report pain score ranging from 0 to 10, with 0 defined as no pain at all and 10 as the intolerable pain.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Hui Qiao, M.D. Ph.D. 8615900598163 theyellow@163.com
Contact: Weihong Yang, M.D. 8618917785802 yangweihong@eentanesthesia.com

Locations
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China, Shanghai
Eye, Ear, Nose and Throat Hospital Recruiting
Shanghai, Shanghai, China, 200031
Contact: Hui Qiao, Doctor    021-64377134    qiaohui@eentanesthesia.com   
Sponsors and Collaborators
Eye & ENT Hospital of Fudan University
Investigators
Layout table for investigator information
Study Director: Wenxian Li, M.D. Ph.D. Eye and ENT Hospital of Fudan University
Tracking Information
First Submitted Date  ICMJE July 9, 2019
First Posted Date  ICMJE July 12, 2019
Last Update Posted Date November 3, 2020
Actual Study Start Date  ICMJE November 1, 2019
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
  • Perioperative change of Observer's Assessment of Alertness/Sedation scale (OAA/S) [ Time Frame: 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. ]
    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.
  • Numerical rating scale (NRS) [ Time Frame: Immediately after surgery, the surgeons report NRS only once ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
  • Intraocular pressure [ Time Frame: Intraocular pressure will be measured at two time points: before sedative medication administration and before skin incision. ]
    Measured with Tono-Pen tonometer
  • Bispectral index (BIS) [ Time Frame: Bis will be continuously recorded with BIS monitor from arrival in the operating room to discharge to ward (about 30 minutes after surgery). ]
    Anesthesia depth index
  • Visual analogue scale (VAS) [ Time Frame: 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 ]
    Patient self-report pain score ranging from 0 to 10, with 0 defined as no pain at all and 10 as the intolerable pain.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Study of Different Sedative Medications in Monitored Anesthesia Care During Eye Surgery With Local Anesthesia
Official Title  ICMJE Effective Dose of Dexmedetomidine or Midazolam in Monitored Anesthesia Care for Patients Undergoing Ophthalmologic Surgery With Retrobulbar Nerve Block
Brief 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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Balanced Anesthesia
  • Adjuvants,Anesthesia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Dexmedetomidine
    Dexmedetomidine will be used for perioperative sedation.
    Intervention: Drug: Dexmedetomidine
  • Experimental: Midazolam
    Midazolam will be used for perioperative sedation.
    Intervention: Drug: Midazolam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2019)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hui Qiao, M.D. Ph.D. 8615900598163 theyellow@163.com
Contact: Weihong Yang, M.D. 8618917785802 yangweihong@eentanesthesia.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04018703
Other Study ID Numbers  ICMJE MAC in Eye Surgery
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hui Qiao, Eye & ENT Hospital of Fudan University
Study Sponsor  ICMJE Eye & ENT Hospital of Fudan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Wenxian Li, M.D. Ph.D. Eye and ENT Hospital of Fudan University
PRS Account Eye & ENT Hospital of Fudan University
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP