Investigation of the Strategy of Preventing Post-operative Opioid-induced Hyperalgesia

NCT ID: NCT03812003

Last Updated: 2019-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-11
• Study Completion Date: 2019-12-31

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

Conditions

Opioid-Induced Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

remifentanil

After emergence and extubation of endotracheal tube, remifentanil 1mcg/kg were diluted with 0.9% saline to 50 ml, added in IV bag, and drip for 30 minutes.

Group Type: EXPERIMENTAL

Remifentanil

Intervention Type: DRUG

remifentanil 1mcg/kg added in 0.9% saline and diluted to 50ml

no intervention

After emergence and extubation of endotracheal tube, 0.9% saline 50ml were added in IV bag and drip for 30 minutes.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Remifentanil

remifentanil 1mcg/kg added in 0.9% saline and diluted to 50ml

Intervention Type: DRUG

Other Intervention Names

Remifentanil ALVOGEN powder

Eligibility Criteria

Inclusion Criteria

• Subject's ASA (American Society of Anesthesiologists) Physical Status Classification: I (A normal healthy patient)~III(A patient with severe systemic disease)
• Subject has breast cancer and scheduled for breast surgery using total-intravenous anesthesia(TIVA)

Exclusion Criteria

• Subject's ASA (American Society of Anesthesiologists) Physical Status Classification >3
• Subject doesn't receive total-intravenous anesthesia(TIVA) during surgery
• Subject has psychiatric disease
• allergic to opioid or propofol
• History of alcoholism
• History of drug abuse

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tri-Service General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wei-Hung Chan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jyh-cherng Yu, MD

Role: STUDY_CHAIR

Tri-Service General Hospital

Locations

Tri-Service General Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Wei-Hung Chan, MD

Role: CONTACT

whcken@gmail.com

886-2-78923311 ext. 12546

Zhi-Fu Wu, MD

Role: CONTACT

aneswu@gmail.com

886-2-78923311 ext. 12852

Facility Contacts

Wei-Hung Chan, Doctorate

Role: primary

whcken@gmail.com

886-2-87923311 ext. 12546

Other Identifiers

2-107-05-162

Identifier Type: -

Identifier Source: org_study_id