The Effects of General Anesthesia and Combined Anesthesia in Controlled Hypotension During Arthroscopic Shoulder Surgery

Sponsor
General Hospital of Ningxia Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05451550
Collaborator
(none)
100
1
3
40.4
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Brachial plexus block
  • Procedure: General anesthesia
  • Procedure: Suprascapular nerve block
N/A

Detailed Description

Controlled hypotension is one of the important techniques used for minimizing bleeding and facilitates the clarity of the surgical field during arthroscopic shoulder surgery. Although surgical field visualization is important in arthroscopic shoulder surgery, the complications associated with controlled hypotension for surgery should be considered. The implementation of controlled hypotension requires a large amount of antihypertensive agents or anesthetics, it may cause instability of the circulatory system, organ hypoperfusion, or subsequent ischemic injury. Brachial plexus or its branches block provides excellent analgesia during arthroscopic shoulder surgery. However, few data are currently available in the literature evaluating brachial plexus or its branches block and controlled hypotension during arthroscopic shoulder surgery. To obtain more information on this topic, the investigators conducted this prospective randomized study to test the hypothesis that, during arthroscopic shoulder surgery, general anesthesia combined with nerve block could provide more stable hemodynamic index than general anesthesia.

Methods:

The inclusion criteria are (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. The exclusion criteria were (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.

The included patients were divided into 3 groups: general anesthesia group, general anesthesia combined with brachial plexus block, and general anesthesia combined with suprascapular nerve block group. For controlled hypotension during surgery, all patients were maintained with propofol/remifentanil in general anesthesia. An additional ultrasound-guided brachial plexus block or suprascapular nerve block were performed in general anesthesia combined with brachial plexus block or general anesthesia combined with suprascapular nerve block group. The dose of each agent was adjusted to maintain the mean arterial blood pressure (MAP) at 60 to 70 mm Hg and the BIS at 40 to 60. nicardipine and phenylephrine served mainly to control the target MAP, Norepinephrine and esmolol were also used as needed.

The dosage of vasoactive drugs (vasopressor-inotrope dose was calculated by adding norepinephrine equivalents of total norepinephrine, epinephrine, phenylephrine, and vasopressin dose used during surgery, using the following formula: total vasopressor-inotrope dose = [norepinephrine (µg/min) × min] + [epinephrine (µg/min) × min] + [(phenylephrine (µg/min) ×min) ÷ 10] + [vasopressin (U/h) × 8.33 × min]) and anesthetics, parameters of perioperative bleeding, hemodynamic parameters(blood pressure, heart rate, pulse oximetry), systemic oxygen metabolism, kidney functions, as well as procedure process and postoperative adverse reactions were recorded and compared between the groups. The incidence of postoperative complications (within 7 days, such as Organ dysfunction) were also recorded.

Statistical analysis and get conclusions.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Effects and Safety in Providing Controlled Hypotension During Arthroscopic Shoulder Surgery Between General Anesthesia and General Anesthesia Combined With Nerve Block
Anticipated Study Start Date :
Jul 17, 2022
Anticipated Primary Completion Date :
Sep 29, 2024
Anticipated Study Completion Date :
Nov 29, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: General anesthesia group

Patients were maintained with propofol/remifentanil in general anesthesia

Procedure: General anesthesia
General anesthesia were performed according to clinical routine: induction drugs: propofol, sufentanil, rocuronium, maintenance drugs: propofol, sevoflurane and remifentanil, Laryngeal mask ventilation.

Experimental: General anesthesia combined with brachial plexus block group

An additional ultrasound-guided brachial plexus block were performed

Procedure: Brachial plexus block
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
Other Names:
  • General anesthesia combined with brachial plexus block group
  • Procedure: General anesthesia
    General anesthesia were performed according to clinical routine: induction drugs: propofol, sufentanil, rocuronium, maintenance drugs: propofol, sevoflurane and remifentanil, Laryngeal mask ventilation.

    Experimental: general anesthesia combined with suprascapular nerve block group

    An additional ultrasound-guided suprascapular nerve block were performed

    Procedure: General anesthesia
    General anesthesia were performed according to clinical routine: induction drugs: propofol, sufentanil, rocuronium, maintenance drugs: propofol, sevoflurane and remifentanil, Laryngeal mask ventilation.

    Procedure: Suprascapular nerve block
    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
    Other Names:
  • General anesthesia combined with suprascapular nerve block group
  • Outcome Measures

    Primary Outcome Measures

    1. The dosage of total vasopressor-inotrope dose between groups [1 day]

      The dosage of total vasopressor-inotrope dose (Calculate by formula) between the groups

    Secondary Outcome Measures

    1. The dosage of anesthetics between groups [1 day]

      The dosage of propofol(milligram) and sevoflurane(milliliter) between groups

    2. Blood pressure between the groups [1 day]

      Blood pressure(millimeter of mercury) between the groups

    3. The incidence of postoperative complications [3 day]

      The incidence of postoperative complications (within 7 days, such as Organ dysfunction) between groups

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • (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.
    Exclusion Criteria:
    • (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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anesthesiology, General Hospital of Ningxia Medical University Yinchuan Ningxia China 750004

    Sponsors and Collaborators

    • General Hospital of Ningxia Medical University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    General Hospital of Ningxia Medical University
    ClinicalTrials.gov Identifier:
    NCT05451550
    Other Study ID Numbers:
    • Gang202207
    First Posted:
    Jul 11, 2022
    Last Update Posted:
    Jul 19, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 19, 2022