Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2026-01-02 @ 1:13 PM
Study NCT ID:
NCT03812003
Status:
UNKNOWN
Last Update Posted:
2019-01-22
First Post:
2019-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Strategy of Preventing Post-operative Opioid-induced Hyperalgesia
Sponsor:
Tri-Service General Hospital
Organization:
Study Overview
Official Title:
Investigation of the Strategy of Preventing Post-operative Opioid-induced Hyperalgesia by Remifentanil Infusion
Status:
UNKNOWN
Status Verified Date:
2019-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The concept of Enhanced Recovery After Surgery(ERAS) has been prevalent in recent years. In the ERAS guideline, short-acting anesthetics, instead of long-acting opioid anesthetics, were recommended during surgery to decrease post-operative complication and length of hospital stay. Propofol-remifentanil based total intravenous anesthesia (TIVA) can provide quicker emergence and decreased post-operative nausea and vomiting. However, the prescription of opioid (especially remifentanil) may induce opioid-induced hyperalgesia (OIH) and increase the requirement of analgesics. Previous studies provided some strategies to prevent OIH. The purpose of this study is to investigate the effect of adding remifentanil(1 mcg/kg) after emergence and endotracheal extubation in breast cancer females receiving breast surgery under propofol-remifentanil based TIVA for the prevention of OIH.
Detailed Description:
1. After obtaining informed consent, patients will be randomized into two groups.
2. All patients receive remifentanil-propofol based TIVA and Bispectral index (BIS) monitor during breast surgery. In the end of surgery, intravenous NSAID(keto) 30mg and local anestehsia (Marcaine) infiltration around the surgical wound will be prescribed to reduce post-operative pain.
3. group R(intervention): remifentanil 1mcg/kg diluted with 0.9% saline to 50ml and drip for 30 minutes after emergence and extubation of endotracheal tube
4. group N(no intervention): 0.9% saline 50ml drip for 30 minutes after emergence and extubation of endotracheal tube
5. In post-anesthesia room: record the numerical rating scale (NRS); requirement of additional analgesics (rescue medication), blood pressure, heart rate, pulse oximeter, degree of nausea, vomiting
6. In ward: record the numerical rating scale (NRS) and total analgesics consumption
2. All patients receive remifentanil-propofol based TIVA and Bispectral index (BIS) monitor during breast surgery. In the end of surgery, intravenous NSAID(keto) 30mg and local anestehsia (Marcaine) infiltration around the surgical wound will be prescribed to reduce post-operative pain.
3. group R(intervention): remifentanil 1mcg/kg diluted with 0.9% saline to 50ml and drip for 30 minutes after emergence and extubation of endotracheal tube
4. group N(no intervention): 0.9% saline 50ml drip for 30 minutes after emergence and extubation of endotracheal tube
5. In post-anesthesia room: record the numerical rating scale (NRS); requirement of additional analgesics (rescue medication), blood pressure, heart rate, pulse oximeter, degree of nausea, vomiting
6. In ward: record the numerical rating scale (NRS) and total analgesics consumption
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: