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

Primary Purpose

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

Status

Recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

S-ketamine

Placebo

About this trial

This is an interventional treatment trial for S-ketamine

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

S-ketamine group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

NRS pain score at rest and with movement

Pain is assessed with a numeric rating scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain)

Full Information

NCT ID

NCT05299866

First Posted

February 26, 2022

Last Updated

February 25, 2023

Sponsor

Ling Dong

1. Study Identification

Unique Protocol Identification Number

NCT05299866

Brief Title

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

Official Title

The Effect of Low-dose of S-ketamine Combined With Sufentanil for Postoperative Patient-controlled Intravenous Analgesia in Patients Following Cesarean Section

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 12, 2022 (Actual)

Primary Completion Date

May 31, 2024 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Ling Dong

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

S-ketamine group

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

S-ketamine

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

The percentage of patients with moderate-to-severe pain

Description

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.

Time Frame

Up to 48 hours after surgery

Secondary Outcome Measure Information:

Title

NRS pain score at rest and with movement

Description

Pain is assessed with a numeric rating scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain)

Time Frame

Hour 12 & Hour 24 & Hour 48 after surgery

Other Pre-specified Outcome Measures:

Title

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

Description

The total number of presses of PCA

Time Frame

Up to 48 hours after surgery

Title

The percentage of using rescue analgesics

Description

The percentage of using rescue analgesics

Time Frame

Up to 48 hours after surgery

Title

The Richmond Agitation-Sedation Scale(RASS)

Description

Sedation is assessed with a numeric rating scale(RASS;an 10-point scale with -5 to +4)

Time Frame

Hour 12 & Hour 24 & Hour 48 after surgery

Title

The incidence of postoperative adverse event

Description

postoperative adverse event with nausea,vomiting,dizziness,nightmares, hallucination and etc

Time Frame

Up to 48 hours after surgery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status II Patients aged between 20 and 40 years 18 kg/m² ≤BMI≤30 kg/m² singleton term pregnancy scheduled for elective cesarean section Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ling Dong, Ph.D

Phone

18866862815

dongling1668@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ling Dong, MD

Phone

18866862815

dongling1668@163.com

Facility Information:

Facility Name

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

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ling Dong, Ph.D

Phone

18866862815

dongling1668@163.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30570761

Citation

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.

Results Reference

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PubMed Identifier

29870457

Citation

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.

Results Reference

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PubMed Identifier

27418219

Citation

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.

Results Reference

background

PubMed Identifier

27118118

Citation

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.

Results Reference

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

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