Vasopressin to Prevent Hypotension During Beach Chair Surgery
This study is currently recruiting participants.
Verified September 2012 by Chonnam National University Hospital
Sponsor:
Chonnam National University Hospital
Collaborator:
Chonnam National University
Information provided by (Responsible Party):
Kyung Yeon Yoo, Chonnam National University Hospital
ClinicalTrials.gov Identifier:
NCT01687894
First received: September 8, 2012
Last updated: September 15, 2012
Last verified: September 2012
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Purpose
Patients undergoing surgery in beach chair position (BCP) are at risk for cerebral ischaemia. The impacts of arginine vasopressin (AVP) on haemodynamics and cerebral oxygenation are evaluated during surgery in BCP.
| Condition | Intervention |
|---|---|
|
Rotator Cuff Tear Arthropathy |
Drug: Vasopressins Drug: Placebo Drug: propofol Drug: sevoflurane |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Clinical Trials of Vasopressin for Prevention of Hypotension During Shoulder Surgery in Beach Chair Position Under General Anesthesia |
Resource links provided by NLM:
Drug Information available for:
Arginine
Argipressin
Arginine Hydrochloride
Propofol
Vasopressin
Sevoflurane
U.S. FDA Resources
Further study details as provided by Chonnam National University Hospital:
Primary Outcome Measures:
- The magnitude of decrease of mean arterial pressure [ Time Frame: Baseline (before positioning) and lowest value within 10 min into beach chair position ] [ Designated as safety issue: Yes ]Continuously measure mean arterial blood pressure before and after position change. Calculate the magnitude of maximum decrease of mean arterial pressure from baseline
Secondary Outcome Measures:
- Jugular venous oxygen desaturation [ Time Frame: Up to 30 min after the positioning ] [ Designated as safety issue: Yes ]Jugular venous oxygen saturation is continuously measured whether its saturation is decreased below 50% or/and 40% for longer than 5 min.
Other Outcome Measures:
- Cerebral oxygen desaturation [ Time Frame: Up to 30 min after the position change ] [ Designated as safety issue: Yes ]Continuously observe near-infrared spectroscopy measured cerebral oxygenation before and after beach chair position whether oxygen saturation decrease more than 20% from pre-sitting values
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Vasopressins & propofol
Administer vasopressin 0.05 or 0.07 IU/kg before sitting position during propofol anesthesia.
|
Drug: Vasopressins
Vasopressins propofol vasopressins sevoflurane
Other Name: Arginine vasopressin
Drug: propofol
vasopressin propofol & placebo propofol
Other Name: Intravenous anesthetic
|
|
Placebo & propofol
Administer saline 10 ml (placebo) 2 min before beach chair position during propofol anesthesia
|
Drug: Placebo
Placebo propofol & placebo sevoflurane
Other Name: saline 10 ml as placebo
Drug: propofol
vasopressin propofol & placebo propofol
Other Name: Intravenous anesthetic
|
|
Vasopressins & sevoflurane
Administer vasopressin 0.05 or 0.07 IU/kg 2 min before beach chair position during sevoflurane anesthesia
|
Drug: Vasopressins
Vasopressins propofol vasopressins sevoflurane
Other Name: Arginine vasopressin
Drug: sevoflurane
vasopressins sevoflurane placebo sevoflurane
Other Name: general anesthetic
|
|
Placebo & sevoflurane
Placebo (saline 10 ml) for vasopressin is administered 2 min before beach chair position during sevoflurane anesthesia
|
Drug: Placebo
Placebo propofol & placebo sevoflurane
Other Name: saline 10 ml as placebo
Drug: sevoflurane
vasopressins sevoflurane placebo sevoflurane
Other Name: general anesthetic
|
Detailed Description:
Patients undergoing shoulder surgery in BCP under general anaesthesia are randomly allocated to receive i.v. normal saline (control group) or AVP 0.05 or 0.07 U kg-1 (AVP group, n = 15 each) 2 min before moving into BCP. Mean arterial pressure (MAP), heart rate (HR), jugular venous bulb oxygen saturation (SjvO2) and regional cerebral tissue oxygen saturation (SctO2) are measured before (pre-sitting in supine position) and after patients assumed BCP.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients undergoing shoulder surgery in the beach chair position under the general anesthesia
Criteria
Inclusion Criteria: elective arthroscopic shoulder surgery under general anesthesia in beach chair position
Exclusion Criteria: preexisting cerebrovascular diseases, history of orthostatic hypotension, age less than 18 yr, and the American Society of Anesthesiologists physical status IV or V
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687894
Contacts
| Contact: Hye J Jeong, M.D. | 82-62-220-6893 ext 6895 | pan79@hanmail.net |
| Contact: Kyung Y Yoo, M.D.,Ph.D. | 82-62-220-6884 ext 6893 | kyyoo@jnu.ac.kr |
Locations
| Korea, Republic of | |
| Department of Anesthesiology and Pain Medicine | Recruiting |
| Gwangju, Korea, Republic of, 501-757 | |
| Contact: Young W Won 82-62-220-6893 ext 6895 ywwon@jnu.ac.kr | |
| Contact: Kyung Y Yoo, M.D.,Ph.D. 82-62-220-6884 ext 6895 kyyoo@jnu.ac.kr | |
| Principal Investigator: Kyung Y Yoo, M.D.,Ph.D. | |
Sponsors and Collaborators
Chonnam National University Hospital
Chonnam National University
Investigators
| Principal Investigator: | Kyung Y Yoo, M.D.,Ph.D | Department of Anesthesiology and Pain Medicine, Chonnam National University Hospital |
More Information
No publications provided
| Responsible Party: | Kyung Yeon Yoo, Professor, Chonnam National University Hospital |
| ClinicalTrials.gov Identifier: | NCT01687894 History of Changes |
| Other Study ID Numbers: | CNUH-2012-074 |
| Study First Received: | September 8, 2012 |
| Last Updated: | September 15, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Chonnam National University Hospital:
|
cerebral oxygen saturation beach chair position hemodynamic jugular venous oximetry |
Additional relevant MeSH terms:
|
Hypotension Joint Diseases Vascular Diseases Cardiovascular Diseases Musculoskeletal Diseases Anesthetics, General Propofol Sevoflurane Anesthetics Arginine Vasopressin Vasopressins Anesthetics, Intravenous Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Hemostatics Coagulants Hematologic Agents Vasoconstrictor Agents Cardiovascular Agents Antidiuretic Agents Natriuretic Agents Hypnotics and Sedatives Platelet Aggregation Inhibitors Anesthetics, Inhalation |
ClinicalTrials.gov processed this record on May 21, 2013