The Effects of General Anesthesia and Combined Anesthesia in Controlled Hypotension During Arthroscopic Shoulder Surgery
Comparison of Effects and Safety in Providing Controlled Hypotension During Arthroscopic Shoulder Surgery Between General Anesthesia and General Anesthesia Combined With Nerve Block
1 other identifier
interventional
100
1 country
1
Brief Summary
Controlled hypotension is one of the important techniques used for facilitates the clarity of the surgical field during arthroscopic shoulder surgery. Brachial plexus or its branches block provides excellent analgesia during arthroscopic shoulder surgery. To test the hypothesis that, during arthroscopic shoulder surgery, general anesthesia combined with nerve block could provide more stable hemodynamic index than general anesthesia. Patients undergoing arthroscopic shoulder surgery were enrolled and divided into 3 groups: general anesthesia group, general anesthesia combined with brachial plexus block, and general anesthesia combined with suprascapular nerve block group. The dosage of vasoactive drugs and anesthetics, parameters of perioperative bleeding, hemodynamic parameters, systemic oxygen metabolism, kidney functions, as well as procedure process and postoperative adverse reactions were recorded and compared between the groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2022
CompletedFirst Posted
Study publicly available on registry
July 11, 2022
CompletedStudy Start
First participant enrolled
July 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 29, 2025
CompletedJuly 19, 2022
June 1, 2022
2.2 years
June 20, 2022
July 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The dosage of total vasopressor-inotrope dose between groups
The dosage of total vasopressor-inotrope dose (Calculate by formula) between the groups
1 day
Secondary Outcomes (3)
The dosage of anesthetics between groups
1 day
Blood pressure between the groups
1 day
The incidence of postoperative complications
3 day
Study Arms (3)
General anesthesia group
EXPERIMENTALPatients were maintained with propofol/remifentanil in general anesthesia
General anesthesia combined with brachial plexus block group
EXPERIMENTALAn additional ultrasound-guided brachial plexus block were performed
general anesthesia combined with suprascapular nerve block group
EXPERIMENTALAn additional ultrasound-guided suprascapular nerve block were performed
Interventions
An additional ultrasound-guided suprascapular nerve block(0.375% ropivacaine) were performed before general anesthesia induction in general anesthesia combined with brachial plexus block group
General anesthesia were performed according to clinical routine: induction drugs: propofol, sufentanil, rocuronium, maintenance drugs: propofol, sevoflurane and remifentanil, Laryngeal mask ventilation.
An additional ultrasound-guided suprascapular nerve block(0.375% ropivacaine) were performed before general anesthesia induction in general anesthesia combined with brachial plexus block group
Eligibility Criteria
You may qualify if:
- (1) planned elective arthroscopic shoulder surgery, need controlled hypotension under general anesthesia; (2) aged 60-75 years; (3) ASA grade II or III; and (4) estimated operative time \< 120 min.
You may not qualify if:
- (1) preoperative blood pressure systolic ≥ 160 mmHg or diastolic ≥ 100 mmHg or pulse pressure ≥ 60 mmHg; (2) comorbidities of severe cardiovascular disease, including cardiac function grade III or IV, severe aortic stenosis, aortic valve insufficiency, severe coronary heart disease, bradycardia, and atrioventricular block above degree I; (3) history of cerebral infarction, Alzheimer's disease, or cerebrovascular incident; (4) liver and/or kidney dysfunction; (5) severe anemia, shock, hypovolemia, or respiratory dysfunction; (6) previous history of phlebitis or thrombosis, closed-angle glaucoma; and (7) BMI \> 25 or \< 18. Patients with intraoperative blood loss \> 1500 mL or operation time \> 4 h would be further excluded from the analysis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology, General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2022
First Posted
July 11, 2022
Study Start
July 17, 2022
Primary Completion
September 29, 2024
Study Completion
November 29, 2025
Last Updated
July 19, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share