Effect of Dexmedetomidine on Parturient Undergoing Elective Cesarean Section.

December 2, 2019 updated by: The Affiliated Hospital of Xuzhou Medical University

Effects of Dexmedetomidine on Mood and Breastfeeding in Parturient Undergoing Elective Cesarean Section.

The purpose of this study was to investigate whether dexmedetomidine used in the perioperative period of elective cesarean section can improve maternal mood, improve analgesic effect, improve maternal recovery quality, and then make the breastfeeding better.At the same time, this experiment attempts to explore the optimal dose of dexmedetomidine to produce the above effect.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After obtaining the informed consent, parturients were randomly divided into two groups according to the computer-generated random number table, namely, dexmedetomidine group and the control group.Spinal anesthesia is administered to all maternal women undergoing elective cesarean delivery. Immediately after the umbilicus is cut, the infusion of the experimental drug was started until the end of the operation, and the PCIA pump with the study medication is used during 2 days postoperatively.Continuous follow-up for three days after surgery.Follow-up personnel recorded LATCH score, VAS score, quality-of-recovery score and other indicators.In the 6th week after caesarean section, the outcome indicators were collected by electronic questionnaire and telephone follow-up.This randomized controlled trial is aims to prove that dexmedetomidine, used in parturient with elective cesarean section, can improve maternal mood and prolong the duration of breastfeeding.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221000
        • The Affiliated Hospital of Xuzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. ASA class I or II
  2. BMI≦35kg/m2
  3. Greater than 37 weeks gestation
  4. Expressed a desire to breastfeed for a least 3 months postpartum
  5. Elective cesarean section

Exclusion Criteria:

  1. Intraspinal anesthesia contraindication
  2. Twin or fetal Intrauterine distress
  3. Preoperative history of application of analgesia or sedative drug
  4. Severe cardiac and pulmonary dysfunction
  5. History of neurological and psychiatric diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dexmedetomidine group
After umbilical cord was cut, a loading dose of dexmedetomidine was pumped at 0.5ug/kg within 10min, followed by a further infusion of dexmedetomidine at 0.5ug /kg/h until the end of the surgery.Then connected with patient-controlled intravenous analgesia pump (dexmedetomidine 2ug/kg + sufentanil 1.5ug/kg + dolasetron 25mg/100ml saline).
Drug: dexmedetomidine group
After the fetus was delivered, low-dose dexmedetomidine intraoperative infusion, postoperative low-dose dexmedetomidine patient-controlled intravenous analgesia pump(the background infusion is 2 ml/h, the bolus dose is 0.5 ml, the lock time is 15 min).
Other Names:
  • D group
Placebo Comparator: control group
Continuous infusion of saline after the umbilical cord was cut until the end of the operation.Then connected with patient-controlled intravenous analgesia pump (sufentanil 1.5ug/kg + dolasetron 25mg/100ml saline).
Drug: control group
After the fetus was delivered, saline intraoperative infusion, postoperative patient-controlled intravenous analgesia pump(the background infusion is 2 ml/h, the bolus dose is 0.5 ml, the lock time is 15 min) without dexmedetomidine.
Other Names:
  • C group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postpartum depression at sixth week after caesarean section
Time Frame: 6th week postpartum

The Edinburgh Postnatal Depression Scale(EPDS) was used to determine the presence of postpartum depression through an electronic questionnaire in the sixth week after delivery.

The Edinburgh Postnatal Depression Scale(EPDS) consists of 10 items. According to the severity of the symptoms, each item is scored in 4 levels (0, 1, 2, 3 points) with a cumulative maximum score of 30 points.In order to reduce the rate of missed diagnosis, we refer to the previous literature and use 10 points as the diagnostic threshold for postpartum depression. A score of 10 or more is considered as postpartum depression.
6th week postpartum
Self-reported exclusive breastfeeding at sixth week after caesarean section
Time Frame: 6th week postpartum
Self-reported exclusive breastfeeding at sixth week postpartum by telephone follow-up.If exclusive breastfeeding is discontinued, obtain the point of discontinuation.
6th week postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale(HADS) score
Time Frame: Preoperative, 1st day and 2nd day postpartum

Referring to the preoperative HADS score, the HADS on the second day after caesarean section were analyzed to judge the maternal emotional changes.

The Hospital Anxiety and Depression Scale (HADS) includes two subscales of anxiety and depression, 7 questions per subscale, and 14 questions in total.Each question is divided into 4 score levels according to the severity (0, 1, 2, 3 points). The anxiety and depression subscales all use 8 points as the diagnostic threshold, and 8 or more points are considered to have anxiety or depression.

The statistical analysis of this outcome indicator is mainly to regard the scale score as a continuous variable rather than a binary variable.
Preoperative, 1st day and 2nd day postpartum
LATCH breastfeeding assessments
Time Frame: 1st day postpartum
Day-1 LATCH (Latch, Audible swallowing, Type of nipple, Comfort, and Hold/help) breastfeeding assessments.
1st day postpartum
VAS score after cesarean section
Time Frame: 6,12,24 and 48 hours after cesarean section
The basic method of Visual Analogue Scale(VAS) is to use a ruler with a length of about 10 cm, the ruler is marked with 10 scales, and the ends are "0" and "10" respectively. "0" indicate no pain, and "10" indicate unbearable pain. Ask the parturient to mark the position on the ruler that represents her pain level. Follow-up personnel record pain scores based on the location of the marker.
6,12,24 and 48 hours after cesarean section
Quality-of-recovery score
Time Frame: Preoperative, 1st day and 2nd day postpartum

Recovery quality assessment on the second day after delivery via the ObsQoR-11 scale.

The ObsQoR-11 scale focuses on the following 11 items: nausea or vomiting, shivering, dizzy, in control, comfortable, able to hold baby, mobilising alone, personal hygiene, able to feed/nurse baby, moderate pain and severe pain. According to different degrees, each item can be divided into 0-10 points.
Preoperative, 1st day and 2nd day postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Hospital of Xuzhou Medical University

Investigators

  • Study Director: Ming Yan, M.D/Ph.D, The Affiliated Hospital of Xuzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

December 2, 2019

Study Completion (Actual)

December 2, 2019

Study Registration Dates

First Submitted

January 13, 2019

First Submitted That Met QC Criteria

January 15, 2019

First Posted (Actual)

January 16, 2019

Study Record Updates

Last Update Posted (Actual)

December 3, 2019

Last Update Submitted That Met QC Criteria

December 2, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XYFY2019-KL054-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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