the Effect of Different Drugs and Infusion Ways on Degree of Postoperative Comfort

NCT04111328 | Completed Phase 4 DMC

• 1 other identifier: 2019-191-2
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the effect of different drugs and infusion ways on degree of postoperative comfort.Patients undergoing spinal neoplasm surgery receive different patient controlled analgesia(PCA) drugs postoperatively,one group is sufentanil,the other is hydromorphone. Then each drug group will be divided into two subgroups according to the infusion way,intravenously,subcutaneously. During the patient controlled analgesia period, patients' degree of comfort,pain score,sleep quality, the degree of side reaction will be recorded.

Conditions

Analgesia, Patient-Controlled

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale of Comfort level

  The participants' comfort level of the PCA."0" means extremely comfort, "10" means extremely discomfort.

  48 hours after the use of PCA.

Secondary Outcomes (4)

• Ramsay sedation score

  6hours,12hours,24hours and 48 hours after the use of PCA.

• The degree of nausea

  6hours,12hours,24hours and 48 hours after the use of PCA.

• The degree of dizziness

  6hours,12hours,24hours and 48 hours after the use of PCA.

• Pupil diameter

  6hours,12hours,24hours and 48 hours after the use of PCA.

Other Outcomes (1)

• Pittsburgh sleep quality index

  1 day before the surgery,1 month after the surgery.

Study Arms (8)

sufentanil administration intravenously

EXPERIMENTAL

The dose of sufentanil for patient-controlled analgesia is 3.0μg/Kg dissolving in 100ml 0.9% normal saline (NS).The PCA pump is connected to the hand vein.The parameters were set as background dose 1.5 ml/h, PCA dose 1ml, locking time 15 min.

Drug: intravenous sufentanil

sufentanil administration subcutaneously

EXPERIMENTAL

The dose of sufentanil for patient-controlled analgesia is 3.0μg/Kg dissolving in 100ml 0.9%NS.The PCA pump is connected to the deltoid subcutaneously.The parameters were set as background dose 1.5 ml/h, PCA dose 1 ml, locking time 15 min.

Drug: subcutaneous sufentanil

hydromorphone administration intravenously

EXPERIMENTAL

The dose of hydromorphone for patient-controlled analgesia is 0.2mg/Kg dissolving in 100ml 0.9%NS.The PCA pump is connected to the hand vein.The parameters were set as background dose 1.5 ml/h, PCA dose 1 ml, locking time 15 min.

Drug: intravenous hydromorphone

hydromorphone administration subcutaneously

EXPERIMENTAL

The dose of hydromorphone for patient-controlled analgesia is 0.2mg/Kg dissolving in 100ml 0.9%NS.The PCA pump is connected to the deltoid subcutaneously.The parameters were set as background dose 1.5 ml/h, PCA dose 1 ml, locking time 15 min.

Drug: subcutaneous hydromorphone

sufentanil and dexmedetomidine intravenously

EXPERIMENTAL

The dose of sufentanil, dexmedetomidine,for patient-controlled analgesia is 3.0μg/Kg, dissolving in 100ml 0.9% normal saline (NS).The PCA pump is connected to the hand vein.The parameters were set as background dose 1.5 ml/h, PCA dose 1ml, locking time 15 min.

Drug: intravenous sufentanil and dexmedetomidine

sufentanil and dexmedetomidine subcutaneously

EXPERIMENTAL

The dose of sufentanil ,dexmedetomidine ,for patient-controlled analgesia is 3.0μg/Kg dissolving in 100ml 0.9%NS.The PCA pump is connected to the deltoid subcutaneously.The parameters were set as background dose 1.5 ml/h, PCA dose 1 ml, locking time 15 min.

Drug: subcutaneous sufentanil and dexmedetomidine

hydromorphone and dexmedetomidine intravenously

EXPERIMENTAL

The dose of hydromorphone for patient-controlled analgesia is 0.2mg/Kg ,dexmedetomidine ,for patient-controlled analgesia is 3.0μg/Kg dissolving in 100ml 0.9%NS.The PCA pump is connected to the hand vein.The parameters were set as background dose 1.5ml/h, PCA dose 1ml, locking time 15 min.

Drug: intravenous hydromorphone and dexmedetomidine

hydromorphone and dexmedetomidine subcutaneously

EXPERIMENTAL

The dose of hydromorphone for patient-controlled analgesia is 0.2mg/Kg ,dexmedetomidine ,for patient-controlled analgesia is 3.0μg/Kg dissolving in 100ml 0.9%NS.The PCA pump is connected to the deltoid subcutaneously.The parameters were set as background dose 1.5ml/h, PCA dose 1 ml, locking time 15 min.

Drug: subcutaneous hydromorphone and dexmedetomidine

Interventions

intravenous sufentanil DRUG

The PCA pumps contain sufentanil . And the pump is connected to participants intravenously .

Also known as: SI

sufentanil administration intravenously

subcutaneous sufentanil DRUG

The PCA pumps contain sufentanil. And the pump is connected to participants subcutaneously.

Also known as: SS

sufentanil administration subcutaneously

intravenous hydromorphone DRUG

The PCA pumps contain hydromorphone. And the pump is connected to participants intravenously .

Also known as: HI

hydromorphone administration intravenously

subcutaneous hydromorphone DRUG

The PCA pumps contain hydromorphone. And the pump is connected to participants subcutaneously.

Also known as: HS

hydromorphone administration subcutaneously

intravenous sufentanil and dexmedetomidine DRUG

The PCA pumps contain sufentanil and dexmedetomidine. And the pump is connected to participants intravenously .

Also known as: SDI

sufentanil and dexmedetomidine intravenously

subcutaneous sufentanil and dexmedetomidine DRUG

The PCA pumps contain sufentanil and dexmedetomidine. And the pump is connected to participants subcutaneously.

Also known as: SDS

sufentanil and dexmedetomidine subcutaneously

intravenous hydromorphone and dexmedetomidine DRUG

The PCA pumps contain hydromorphone and dexmedetomidine. And the pump is connected to participants intravenously.

Also known as: HDI

hydromorphone and dexmedetomidine intravenously

subcutaneous hydromorphone and dexmedetomidine DRUG

The PCA pumps contain hydromorphone and dexmedetomidine. And the pump is connected to participants subcutaneously

Also known as: HDS

hydromorphone and dexmedetomidine subcutaneously

Eligibility Criteria

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

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I or II .

You may not qualify if:

• history of severe heart, hepatic or renal disease,
• history of chronic pain condition or opioid use,
• body mass index (BMI) ≤18 or ≥30 kg/m2,
• alcohol or drug abuse,
• relevant drug allergy,
• inability to properly describe postoperative pain,
• inability to use PCA pump.

Sponsors & Collaborators

• Jun Wang: lead

Study Sites (1)

The First Affiliated Hosipital of China Medical University

Shenyang, Liaoning, China

Location

Related Publications (1)

• Wang J, Cui L, Fan L, Wang J. Clinical Effect of Different Drugs and Infusion Techniques for Patient-controlled Analgesia After Spinal Tumor Surgery: A Prospective, Randomized, Controlled Clinical Trial. Clin Ther. 2021 Jun;43(6):1020-1028. doi: 10.1016/j.clinthera.2021.03.019. Epub 2021 May 2.

  PMID: 33952398 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: October 1, 2019
• Study Start: October 8, 2019
• Primary Completion: September 30, 2020
• Study Completion: October 30, 2020
• Last Updated: February 9, 2021

Record last verified: 2020-07

Locations

CN (1)