The Efficacy and Optimal Dose of Sufentanil in Patient Controlled Analgesia After Moderate Surgery

NCT02503826 | Unknown Phase 4

• 1 other identifier: LLGZB-FS-003-01
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Effective postoperative pain control is essential for patients and inadequate postoperative pain relief can cause mental and psychological sufferings. Despite the growing concern on postoperative pain management, acute postoperative pain is still poorly managed. Though numerous clinical practice guidelines for postoperative pain management have been published throughout the last decades, inadequate pain relief remain a big health care issue. Sufentanil has been used as satisfied pain control drug because of its strong potency of analgesia for a long while. But its use in patient controlled intravenous analgesia (PCIA) has not been clarified. And the dilemma of safety concern and insufficient dosage of analgesic is a common problem. Thus the investigators design this prospective randomized controlled double blinded trial to observe the efficacy and the optimal dose of sufentanil in PCIA in patients underwent moderate surgery for the purpose of providing reference in clinical practice.

Conditions

Analgesia, Patient-Controlled; Gastrectomy; Arthroplasty

Outcome Measures

Primary Outcomes (2)

• Change of Pain on the VAS scale after surgery

  2, 6, 24 and 48hrs after surgery

• Change of Pain on the NRS scale after surgery

  2, 6, 24 and 48hrs after surgery

Study Arms (3)

1.5 SF

EXPERIMENTAL

Sufentanil,1.5mcg/kg

Drug: Sufentanil; Drug: Midazolam; Drug: propofol; Drug: cisatracurium

2.0 SF

EXPERIMENTAL

Sufentanil, 2.0mcg/kg

Drug: Sufentanil; Drug: Midazolam; Drug: propofol; Drug: cisatracurium

2.5 SF

EXPERIMENTAL

Sufentanil, 2.5mcg/kg

Drug: Sufentanil; Drug: Midazolam; Drug: propofol; Drug: cisatracurium

Interventions

Sufentanil DRUG

low dose

Also known as: Renfu Pharmacy

1.5 SF

Midazolam DRUG

Midazolam 2 mg, sufentanil 0.5 mcg/kg, propofol 2 mg/kg, cisatracurium 2 mg/kg for induction, continuous infusion of propofol, remifentanil and cisatracurium to maintain bispectral index (BIS) value between 40 and 60 for maintenance.

1.5 SF; 2.0 SF; 2.5 SF

propofol DRUG

1.5 SF; 2.0 SF; 2.5 SF

cisatracurium DRUG

1.5 SF; 2.0 SF; 2.5 SF

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 75 years old,
• BMI 18 to 28kg/m2,
• ASA I to II grade,
• anticipated surgery duration within 4hrs,
• agree to sign consent paper.

You may not qualify if:

• severe respiratory,
• cardiovascular or neurological disease,
• hepatic or renal dysfunction,
• psychiatric history or with unstable mental state,
• drug addiction or dependence

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

MeSH Terms

Conditions

Agnosia

Interventions

Sufentanil; Midazolam; Propofol; cisatracurium

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending doctor

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: July 21, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Last Updated: July 21, 2015

Record last verified: 2015-07