Combination of Nalbuphine and Dexmedetomidine Versus Sufentanil and Dexmedetomidine on Patients

NCT05445024 | Unknown

• 1 other identifier: LM-WWW-2022
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Surgical pain refers to pain that occurs immediately after surgery, including physical pain and visceral pain. Thus, it severely challenges the proper use of analgesics for patients undergoing laparoscope gastrointestinal surgery to clinicians. Nalbuphine is a mixed agonist-antagonist opioid. The investigators hypothesized that the clinical effect of nalbuphine in combination with dexmedetomidine might be different from that of sufentanil in combination with dexmedetomidine. So, the investigators performed a nalbuphine and dexmedetomidine dose finding study, for the patient controlled anaesthesia (PCA) after the laparoscopic gastrointestinal surgery, to establish their 95% effective dose (ED95). The investigators then compared the clinical effect and adverse events of the newly established dosing regimen of nalbuphine combined with dexmedetomidine, to the equivalent dosing of sufentanil combined with dexmedetomidine, in the same patient population.

Conditions

Laparoscopic; Gastrointestinal Surgery

Keywords

laparoscopic; gastrointestinal surgery; nalbuphine; sufentanil; patient-controlled intravenous analgesia; dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS) at rest

  VAS = a 10 cm VAS for pain (0, no pain; 10, worst imaginable pain)

  At 24 hour after operation

Secondary Outcomes (26)

• VAS upon movement

  Before leaving post anesthesia care(T0) and at 6 hour(T1), 12 hour(T2), 18 hour(T3), 24 hour(T4) and 48 hour (T5)postoperatively.T0 is defined as before the patients leave PACU.T1-T5 were defined as 6,12,18,24 and 48 hour postoperatively, respectively.

• VAS at rest

  At 6 hour(T1), 12 hour(T2), 18 hour(T3) ,48 hour(T5) postoperatively.T1 is defined as 6 hour after surgery.T2 is defined as 12 hour after surgery.T3 is defined as 18 hour after surgery.T5 is defined as 48 hour after surgery.

• VAS at rest

  Before leaving post anesthesia care unit (PACU)(T0) .T0 is defined as before the patients leave PACU.

• Brinell comfort score (BCS)

  Before leaving PACU(T0) and at 6 hour(T1), 12 hour(T2), 18 hour(T3), 24 hour(T4) and 48 hour (T5)postoperatively.T0 is defined as before the patients leave PACU.T1-T5 were defined as 6,12,18,24 and 48 hour postoperatively, respectively.

• pressing times of PCIA

  Before leaving PACU(T0) and at 6 hour(T1), 12 hour(T2), 18 hour(T3), 24 hour(T4) and 48 hour (T5)postoperatively.T0 is defined as before the patients leave PACU.T1-T5 were defined as 6,12,18,24 and 48 hour postoperatively, respectively.

Study Arms (2)

nalbuphine group

EXPERIMENTAL

nalbuphine ED95, dexmedetomidine ED95 and ondansetron 16mg were added into normal saline to a total of 100ml

Procedure: nalbuphine group

sufentanil group

PLACEBO COMPARATOR

sufentanil (1/1000\* nalbuphine ED95), dexmedetomidine ED95 and ondansetron 16mg were added into normal saline to a total of 100ml

Procedure: sufentanil group

Interventions

nalbuphine group PROCEDURE

nalbuphine ED95, dexmedetomidine ED95 and ondansetron 16mg were added into normal saline to a total of 100ml

nalbuphine group

sufentanil group PROCEDURE

sufentanil (1/1000\* nalbuphine ED95), dexmedetomidine ED95 and ondansetron 16mg were added into normal saline to a total of 100ml

sufentanil group

Eligibility Criteria

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

You may qualify if:

• age ≥18 years and ≤75 years;
• scheduled to undergo laparoscopic gastrointestinal surgery, under general anaesthesia;
• kg/m2≤BMI≤27.9kg /m2;
• American Society of Anesthesiology (ASA) I-III;
• agree to participate, and give signed written informed consents;
• Verbal or reading ability, able to understand and complete the questionnaire independently or with the help of doctors.

You may not qualify if:

• patients who were allergic to the drugs in this study, who refused to use analgesic devices and analgesic drugs after operation, or who refused to sign the consent forms were not included;
• severe hypertension, severe psychiatric disease and mental system diseases, severe respiratory diseases, hyperthyroidism, severe liver and kidney dysfunction, alcohol or drug abuse, Severe heart dysfunction or pulmonary insufficiency,Previous history of schizophrenia, epilepsy, myasthenia gravis or delirium;
• Patients who had a history of drug abuse, patients undergoing chemotherapy and radiotherapy one month before operation, patients unwilling to cooperate with the treatment or with disabilities, were excluded from the study;
• Patients with a definite diagnosis of chronic pain syndrome, or substance use disorder, patients who used sedatives, antiemetics, or anti-pruritic agents within 24 h before operation;
• participating in other clinical studies in recent 3 months.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

Meng-Lv

Jinan, Shandong, 250000, China

RECRUITING

Study Officials

• Meng Lv, doctor

  Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meng Lv

CONTACT

15169105373; qylvmeng@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: July 6, 2022
• Study Start: January 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: April 4, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)