The Effect of S-ketamine Combined With Sufentanil for Postoperative Analgesia in Patients Following Cesarean Section

NCT05299866 | Unknown Phase 4

• 1 other identifier: YXLL-KY-2021(071)
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial is designed to investigate the effect of low-dose of S-ketamine combined with sufentanil for postoperative patient-controlled intravenous analgesia in patients following cesarean section.

Conditions

S-ketamine; Analgesia, Patient-Controlled; Cesarean Section

Outcome Measures

Primary Outcomes (1)

• The percentage of patients with moderate-to-severe pain

  Moderate-to-severe pain is defined as a numeric rating scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain) pain score ≥4.

  Up to 48 hours after surgery

Secondary Outcomes (1)

• NRS pain score at rest and with movement

  Hour 12 & Hour 24 & Hour 48 after surgery

Other Outcomes (4)

• The total number of presses of Patient-controlled Analgesia (PCA)

  Up to 48 hours after surgery

• The percentage of using rescue analgesics

  Up to 48 hours after surgery

• The Richmond Agitation-Sedation Scale(RASS)

  Hour 12 & Hour 24 & Hour 48 after surgery

Study Arms (2)

S-ketamine group

EXPERIMENTAL

The pump is established with S-ketamine 1mg/kg, sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml.

Drug: S-ketamine

Control group

PLACEBO COMPARATOR

The pump is established with sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml.

Drug: Placebo

Interventions

S-ketamine DRUG

After surgery, patient-controlled analgesia is provided. The pump is established with S-ketamine 1mg/kg, sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml. The pump is programmed to deliver 2 ml boluses with a background infusion rate at 2 ml /h and a 30 min lockout interval.

S-ketamine group

Placebo DRUG

After surgery, patient-controlled analgesia is provided. The pump is established with sufentanil 2microgram/kg, andondansetron16mg, diluted with normal saline to 100 ml. The pump is programmed to deliver 2 ml boluses with a background infusion rate at 2 ml /h and a 30 min lockout interval.

Control group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status II
• Patients aged between 20 and 40 years
• kg/m² ≤BMI≤30 kg/m²
• singleton term pregnancy
• scheduled for elective cesarean section

You may not qualify if:

• Refused to participant in this trial
• Severe heart dysfunction or pulmonary insufficiency
• Poor blood pressure control in those with hypertension (BP \>160/100 mmHg in the ward)
• Previous history of Intracranial hypertension or hyperthyroidism
• Previous history of schizophrenia, epilepsy, myasthenia gravis or delirium
• Allergy to drugs used in the study

Sponsors & Collaborators

• Ling Dong: lead

Study Sites (1)

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

Jinan, Shandong, 250000, China

RECRUITING

Related Publications (4)

• Brinck EC, Tiippana E, Heesen M, Bell RF, Straube S, Moore RA, Kontinen V. Perioperative intravenous ketamine for acute postoperative pain in adults. Cochrane Database Syst Rev. 2018 Dec 20;12(12):CD012033. doi: 10.1002/14651858.CD012033.pub4.

  PMID: 30570761 BACKGROUND

• Schwenk ES, Viscusi ER, Buvanendran A, Hurley RW, Wasan AD, Narouze S, Bhatia A, Davis FN, Hooten WM, Cohen SP. Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Acute Pain Management From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists. Reg Anesth Pain Med. 2018 Jul;43(5):456-466. doi: 10.1097/AAP.0000000000000806.

  PMID: 29870457 BACKGROUND

• Isik Y, Dag ZO, Tulmac OB, Pek E. Early postpartum lactation effects of cesarean and vaginal birth. Ginekol Pol. 2016;87(6):426-30. doi: 10.5603/GP.2016.0020.

  PMID: 27418219 BACKGROUND

• Hobbs AJ, Mannion CA, McDonald SW, Brockway M, Tough SC. The impact of caesarean section on breastfeeding initiation, duration and difficulties in the first four months postpartum. BMC Pregnancy Childbirth. 2016 Apr 26;16:90. doi: 10.1186/s12884-016-0876-1.

  PMID: 27118118 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Esketamine

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ling Dong, Ph.D

CONTACT

18866862815; dongling1668@163.com

Ling Dong, MD

CONTACT

18866862815; dongling1668@163.com

Study Design

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

Study Record Dates

• First Submitted: February 26, 2022
• First Posted: March 29, 2022
• Study Start: April 12, 2022
• Primary Completion: May 31, 2024
• Study Completion: June 30, 2024
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)