Breast FeedingPhase 4NCT03065530

Intravenous Dexmedetomidine for Cesarean Section

A Phase 4 study testing Normal Saline, Dexmedetomidine 0.03ug/kg/h and Dexmedetomidine 0.05ug/kg/h in people with Breast Feeding and Analgesia Obstetrical, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Nervous, anxiety, fear and other psychological reactions always appears in parturients during cesarean section. This study intends to investigate the effectiveness and safety of dexmedetomidine combined with butorphanol tartrate for postoperative analgesia and breastfeeding after caesarean section. Read more about this study

Who is it for?: Ages 24 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Breast Feeding, Analgesia Obstetrical, Postoperative Pain
What is being tested?: Normal Saline, Dexmedetomidine 0.03ug/kg/h and Dexmedetomidine 0.05ug/kg/h
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 1 siteChina
Study dates: 7 Feb 2017to 5 Oct 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 24 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Parturients who had successfully breastfed a prior infant and planned to breastfeed after this delivery were screened for eligibility.
Parturients undergoing elective caesarean delivery under epidural anaesthesia
ASA I and II parturients aged 18-45 years, with singleton gestation.
Parturients with verbal and written mandarin
Parturients who want to use PCA intravenous analgesia and can use the pump correctly
written informed consent.

Who cannot join

Multiple gestation.
A history of allergy to dexmedetomidine or other study drugs
Cardiovascular disease (basic HR<50bpm or SBP<100mmHg)
Opioid drugs abuse.
BMI more than 35 kg/m2
Conditions that preclude spinal anesthesia.

Show all 10Show fewer

Preeclampsia or epilepsy.
A history of neuromuscular disease.
Epidural anaesthesia was unsuccessful.
The parturients, whose surgery ended after 11 a.m.

Trial locations and contacts

1 site in 1 country.

China1 site

The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029

Other trials in China

About this study

Official title: Efficacy and Safety of Dexmedetomidine Combined With Butorphanol Tartrate for Postoperative Analgesia and Breastfeeding in Cesarean Section

Conditions: Breast Feeding, Analgesia Obstetrical, Postoperative Pain
Being tested: Normal Saline, Dexmedetomidine 0.03ug/kg/h, Dexmedetomidine 0.05ug/kg/h, Dexmedetomidine 0.08ug/kg/h
Keywords: Dexmedetomidine, Butorphanol tartrate, Analgesia, Breastfeeding, Relative infant dose
Medical subject headings: Breast Feeding, Pain, Postoperative, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Normal SalineDrug
Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
Dexmedetomidine 0.03ug/kg/hDrug
Also called dexmedetomidine Injection, Dexmedetomidine Hydrochloride
Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.
Dexmedetomidine 0.05ug/kg/hDrug
Also called dexmedetomidine Injection, Dexmedetomidine Hydrochloride
Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.
Dexmedetomidine 0.08ug/kg/hDrug
Also called dexmedetomidine Injection, Dexmedetomidine Hydrochloride
Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.

Study groups in NCT03065530
Study group	Role	What they receive
control group	Placebo comparator	The placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min and receive 1mg butorphanol after delivery. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min. Receives: Drug: Normal Saline
Dexmedetomidine 0.03ug/kg/h group	Experimental	This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min and 1mg butorphanol tartrate after delivery. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min. Receives: Drug: Dexmedetomidine 0.03ug/kg/h
Dexmedetomidine 0.05ug/kg/h group	Experimental	This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min and 1mg butorphanol tartrate after delivery. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min. Receives: Drug: Dexmedetomidine 0.05ug/kg/h
Dexmedetomidine 0.08ug/kg/h group	Experimental	This group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min and 1mg butorphanol tartrate after delivery. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min. Receives: Drug: Dexmedetomidine 0.08ug/kg/h

What is being measured

The primary outcome is the main question the study is designed to answer.

Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest
visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position
Measured: 6h after cesarean section.

Secondary outcomes (17)

Relative Infant Dose (RID) of Dexmedetomidine
Relative infant dose (RID) =Dose (infant, mg•kg-1•day-1) /Dose (mother, mg•kg-1•day-1) μg·kg-1·h-1. The Dose (infant) in mg•kg-1 is calculated by multiplying the concentration of the drug in breast milk by the volume of breast milk consumed daily (about 150 mL•kg-1).
Measured: 48h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest
visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position
Measured: 12h after cesarean section.
Ramsay Sedation Score(RSS)
Sedation intensity measured with RSS is recorded at the 6, 12 24 and 48 h after cesarean section. Sedation was assessed by the Ramsay Sedation Scores (RSS) (1, anxious patient; 2, cooperative and tranquil; 3, responding to command; 4, brisk response to stimulus; 5, sluggish response to stimulus; 6, no response to stimulus).
Measured: 6h after cesarean section.
The Degree of Satisfaction
The degree of satisfaction (0, very satisfied; 1, satisfied; 2, moderately satisfied; 3, not satisfied) was evaluated at 48 h after surgery. The number of overall satisfied patients (satisfied and very satisfied) is reported.
Measured: 48h after cesarean section.
Number of Participants That Experienced Nausea or Vomiting
Total times during 48h after cesarean section.
Measured: 48h after cesarean section.
Ramsay Sedation Score(RSS)
Sedation intensity measured with RSS is recorded at the 6, 12, 24, and 48 h after cesarean section. Sedation was assessed by the Ramsay Sedation Scores (RSS) (1, anxious patient; 2, cooperative and tranquil; 3, responding to command; 4, brisk response to stimulus; 5, sluggish response to stimulus; 6, no response to stimulus).
Measured: 12h after cesarean section.
Ramsay Sedation Score(RSS)
Sedation intensity measured with RSS is recorded at the 6, 12, 24, and 48 h after cesarean section. Sedation was assessed by the Ramsay Sedation Scores (RSS) (1, anxious patient; 2, cooperative and tranquil; 3, responding to command; 4, brisk response to stimulus; 5, sluggish response to stimulus; 6, no response to stimulus).
Measured: 24h after cesarean section.
Ramsay Sedation Score(RSS)
Sedation intensity measured with RSS is recorded at the 6, 12, 24, and 48 h after cesarean section. Sedation was assessed by the Ramsay Sedation Scores (RSS) (1, anxious patient; 2, cooperative and tranquil; 3, responding to command; 4, brisk response to stimulus; 5, sluggish response to stimulus; 6, no response to stimulus).
Measured: 48h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest
visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position
Measured: 24h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS)
visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position
Measured: 48h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement
visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS on movement was assessed when patients changed from supine to lateral position.
Measured: 6h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement
visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS on movement was assessed when patients changed from supine to lateral position.
Measured: 12h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement
visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS on movement was assessed when patients changed from supine to lateral position.
Measured: 24h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement
visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS on movement was assessed when patients changed from supine to lateral position.
Measured: 48h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping
visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS-C was assessed when the patient required oxytocin after surgery in supine position
Measured: 6h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping
visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS-C was assessed when the patient required oxytocin after surgery in supine position
Measured: 12h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping
visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS-C was assessed when the patient required oxytocin after surgery in supine position
Measured: 24h after cesarean section.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Feb 20175 Oct 2017

First posted28 Feb 2017
Study start7 Feb 2017
Primary completion30 Sep 2017
Study completion5 Oct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (30)Papers the sponsor has linked to this study.
Other trials for Breast FeedingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03065530
Sponsor's protocol ID: 2015-SR-203
Status last verified: Jan 2020
First submitted: 18 Feb 2017
Last updated: 13 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Desborough JP. The stress response to trauma and surgery. Br J Anaesth. 2000 Jul;85(1):109-17. doi: 10.1093/bja/85.1.109. No abstract available.
PubMed 10927999
Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available.
PubMed 11020770
Kainu JP, Halmesmaki E, Korttila KT, Sarvela PJ. Persistent Pain After Cesarean Delivery and Vaginal Delivery: A Prospective Cohort Study. Anesth Analg. 2016 Dec;123(6):1535-1545. doi: 10.1213/ANE.0000000000001619.
PubMed 27870738
Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.
PubMed 18818022
Lin TF, Yeh YC, Lin FS, Wang YP, Lin CJ, Sun WZ, Fan SZ. Effect of combining dexmedetomidine and morphine for intravenous patient-controlled analgesia. Br J Anaesth. 2009 Jan;102(1):117-22. doi: 10.1093/bja/aen320. Epub 2008 Nov 5.
PubMed 18987053
Jakob SM, Ruokonen E, Grounds RM, Sarapohja T, Garratt C, Pocock SJ, Bratty JR, Takala J; Dexmedetomidine for Long-Term Sedation Investigators. Dexmedetomidine vs midazolam or propofol for sedation during prolonged mechanical ventilation: two randomized controlled trials. JAMA. 2012 Mar 21;307(11):1151-60. doi: 10.1001/jama.2012.304.
PubMed 22436955
Schnabel A, Meyer-Friessem CH, Reichl SU, Zahn PK, Pogatzki-Zahn EM. Is intraoperative dexmedetomidine a new option for postoperative pain treatment? A meta-analysis of randomized controlled trials. Pain. 2013 Jul;154(7):1140-9. doi: 10.1016/j.pain.2013.03.029. Epub 2013 Mar 27.
PubMed 23706726
Colin PJ, Hannivoort LN, Eleveld DJ, Reyntjens KMEM, Absalom AR, Vereecke HEM, Struys MMRF. Dexmedetomidine pharmacokinetic-pharmacodynamic modelling in healthy volunteers: 1. Influence of arousal on bispectral index and sedation. Br J Anaesth. 2017 Aug 1;119(2):200-210. doi: 10.1093/bja/aex085.
PubMed 28854538
Arain SR, Ruehlow RM, Uhrich TD, Ebert TJ. The efficacy of dexmedetomidine versus morphine for postoperative analgesia after major inpatient surgery. Anesth Analg. 2004 Jan;98(1):153-158. doi: 10.1213/01.ANE.0000093225.39866.75.
PubMed 14693611
Ren C, Chi M, Zhang Y, Zhang Z, Qi F, Liu Z. Dexmedetomidine in Postoperative Analgesia in Patients Undergoing Hysterectomy: A CONSORT-Prospective, Randomized, Controlled Trial. Medicine (Baltimore). 2015 Aug;94(32):e1348. doi: 10.1097/MD.0000000000001348.
PubMed 26266386
Orbach-Zinger S, Fireman S, Ben-Haroush A, Karoush T, Klein Z, Mazarib N, Artyukh A, Chen R, Ioscovich A, Eidelman LA, Landau R. Preoperative sleep quality predicts postoperative pain after planned caesarean delivery. Eur J Pain. 2017 May;21(5):787-794. doi: 10.1002/ejp.980. Epub 2016 Dec 15.
PubMed 27977073
Hsu YW, Cortinez LI, Robertson KM, Keifer JC, Sum-Ping ST, Moretti EW, Young CC, Wright DR, Macleod DB, Somma J. Dexmedetomidine pharmacodynamics: part I: crossover comparison of the respiratory effects of dexmedetomidine and remifentanil in healthy volunteers. Anesthesiology. 2004 Nov;101(5):1066-76. doi: 10.1097/00000542-200411000-00005.
PubMed 15505441
El-Tahan MR, Mowafi HA, Al Sheikh IH, Khidr AM, Al-Juhaiman RA. Efficacy of dexmedetomidine in suppressing cardiovascular and hormonal responses to general anaesthesia for caesarean delivery: a dose-response study. Int J Obstet Anesth. 2012 Jul;21(3):222-9. doi: 10.1016/j.ijoa.2012.04.006. Epub 2012 Jun 7.
PubMed 22681971
Nie Y, Liu Y, Luo Q, Huang S. Effect of dexmedetomidine combined with sufentanil for post-caesarean section intravenous analgesia: a randomised, placebo-controlled study. Eur J Anaesthesiol. 2014 Apr;31(4):197-203. doi: 10.1097/EJA.0000000000000011.
PubMed 24463478
Sia AT, Sng BL. Intravenous dexmedetomidine for obstetric anaesthesia and analgesia: converting a challenge into an opportunity? Int J Obstet Anesth. 2009 Jul;18(3):204-6. doi: 10.1016/j.ijoa.2009.02.008. Epub 2009 May 22. No abstract available.
PubMed 19464877

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Dexmedetomidine Combined With Butorphanol Tartrate for Postoperative Analgesia and Breastfeeding in Cesarean Section
ClinicalTrials.gov ID: NCT03065530
Acronym / sponsor ID: 2015-SR-203
Conditions: Breast Feeding, Analgesia Obstetrical, Postoperative Pain
Keywords: Dexmedetomidine, Butorphanol tartrate, Analgesia, Breastfeeding, Relative infant dose
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
Study start: 7 Feb 2017 (actual)
Primary completion: 30 Sep 2017 (actual)
Study completion: 5 Oct 2017 (actual)
First posted: 28 Feb 2017 (actual)
Results: Posted 13 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
control group	Placebo comparator	Drug: Normal SalineThe placebo group will pumped in the same volume of saline 0.9% as calculated by parturients' weight in 30 min and receive 1mg butorphanol after delivery. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.03ug/kg/h group	Experimental	Drug: Dexmedetomidine 0.03ug/kg/hThis group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min and 1mg butorphanol tartrate after delivery. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.03ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.05ug/kg/h group	Experimental	Drug: Dexmedetomidine 0.05ug/kg/hThis group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min and 1mg butorphanol tartrate after delivery. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.05ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.
Dexmedetomidine 0.08ug/kg/h group	Experimental	Drug: Dexmedetomidine 0.08ug/kg/hThis group will receive 0.5ug/kg intravenous dexmedetomidine diluted to 4ug/ml in 30 min and 1mg butorphanol tartrate after delivery. Postoperative analgesic formula: 3ug/kg/h butorphanol tartrate with 0.08ug/kg/h dexmedetomidine, diluted with normal saline to 100ml. Background dose: 2ml/h, PCA: 0.5ml, locking time: 15 min.

Who may qualify

Ages: 24 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Parturients who had successfully breastfed a prior infant and planned to breastfeed after this delivery were screened for eligibility.
Parturients undergoing elective caesarean delivery under epidural anaesthesia
ASA I and II parturients aged 18-45 years, with singleton gestation.
Parturients with verbal and written mandarin
Parturients who want to use PCA intravenous analgesia and can use the pump correctly

Key exclusion criteria (10 listed)

Multiple gestation.
A history of allergy to dexmedetomidine or other study drugs
Cardiovascular disease (basic HR<50bpm or SBP<100mmHg)
Opioid drugs abuse.
BMI more than 35 kg/m2

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Normal SalineDrug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.	Drug	control group
Dexmedetomidine 0.03ug/kg/hAlso: dexmedetomidine Injection, Dexmedetomidine HydrochlorideDrug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.	Drug	Dexmedetomidine 0.03ug/kg/h group
Dexmedetomidine 0.05ug/kg/hAlso: dexmedetomidine Injection, Dexmedetomidine HydrochlorideDrug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.	Drug	Dexmedetomidine 0.05ug/kg/h group
Dexmedetomidine 0.08ug/kg/hAlso: dexmedetomidine Injection, Dexmedetomidine HydrochlorideDrug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.	Drug	Dexmedetomidine 0.08ug/kg/h group

Primary outcome

Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest
Time frame: 6h after cesarean section.
visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position

17 secondary outcomes

Relative Infant Dose (RID) of Dexmedetomidine
Time frame: 48h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest
Time frame: 12h after cesarean section.
Ramsay Sedation Score(RSS)
Time frame: 6h after cesarean section.
The Degree of Satisfaction
Time frame: 48h after cesarean section.
Number of Participants That Experienced Nausea or Vomiting
Time frame: 48h after cesarean section.
Ramsay Sedation Score(RSS)
Time frame: 12h after cesarean section.
Ramsay Sedation Score(RSS)
Time frame: 24h after cesarean section.
Ramsay Sedation Score(RSS)
Time frame: 48h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest
Time frame: 24h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS)
Time frame: 48h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement
Time frame: 6h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement
Time frame: 12h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement
Time frame: 24h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement
Time frame: 48h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping
Time frame: 6h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping
Time frame: 12h after cesarean section.
Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping
Time frame: 24h after cesarean section.

Results and safety

Results posted to the registry on 13 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group C	30	28
Group D1	30	29
Group D2	30	29
Group D3	30	28

Primary outcome: Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest

Time frame: 6h after cesarean section.. Mean (Standard Deviation). Unit: units on a scale

Measure	Group C n = 28	Group D1 n = 29	Group D2 n = 29	Group D3 n = 28
Value	3.143 (1.38)	2.897 (1.012)	1.665 (1.045)	1.25 (0.7515)

Group C vs Group D1 vs Group D2 vs Group D3: p <0.05, Kruskal-Wallis

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: Every 6 hours post cesarean section, up to 48 hours in total.. Other adverse events reported at 4.4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group C	0 of 28 (0%)	1 of 28 (3.6%)	0 of 28
Group D1	0 of 29 (0%)	2 of 29 (6.9%)	0 of 29
Group D2	0 of 29 (0%)	1 of 29 (3.4%)	0 of 29
Group D3	0 of 28 (0%)	1 of 28 (3.6%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 10927999Desborough JP. The stress response to trauma and surgery. Br J Anaesth. 2000 Jul;85(1):109-17. doi: 10.1093/bja/85.1.109. No abstract available.
Results publication: PubMed 11020770Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available.
Results publication: PubMed 27870738Kainu JP, Halmesmaki E, Korttila KT, Sarvela PJ. Persistent Pain After Cesarean Delivery and Vaginal Delivery: A Prospective Cohort Study. Anesth Analg. 2016 Dec;123(6):1535-1545. doi: 10.1213/ANE.0000000000001619.
Results publication: PubMed 18818022Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.
Results publication: PubMed 18987053Lin TF, Yeh YC, Lin FS, Wang YP, Lin CJ, Sun WZ, Fan SZ. Effect of combining dexmedetomidine and morphine for intravenous patient-controlled analgesia. Br J Anaesth. 2009 Jan;102(1):117-22. doi: 10.1093/bja/aen320. Epub 2008 Nov 5.
Results publication: PubMed 22436955Jakob SM, Ruokonen E, Grounds RM, Sarapohja T, Garratt C, Pocock SJ, Bratty JR, Takala J; Dexmedetomidine for Long-Term Sedation Investigators. Dexmedetomidine vs midazolam or propofol for sedation during prolonged mechanical ventilation: two randomized controlled trials. JAMA. 2012 Mar 21;307(11):1151-60. doi: 10.1001/jama.2012.304.
Results publication: PubMed 23706726Schnabel A, Meyer-Friessem CH, Reichl SU, Zahn PK, Pogatzki-Zahn EM. Is intraoperative dexmedetomidine a new option for postoperative pain treatment? A meta-analysis of randomized controlled trials. Pain. 2013 Jul;154(7):1140-9. doi: 10.1016/j.pain.2013.03.029. Epub 2013 Mar 27.
Results publication: PubMed 28854538Colin PJ, Hannivoort LN, Eleveld DJ, Reyntjens KMEM, Absalom AR, Vereecke HEM, Struys MMRF. Dexmedetomidine pharmacokinetic-pharmacodynamic modelling in healthy volunteers: 1. Influence of arousal on bispectral index and sedation. Br J Anaesth. 2017 Aug 1;119(2):200-210. doi: 10.1093/bja/aex085.
Results publication: PubMed 14693611Arain SR, Ruehlow RM, Uhrich TD, Ebert TJ. The efficacy of dexmedetomidine versus morphine for postoperative analgesia after major inpatient surgery. Anesth Analg. 2004 Jan;98(1):153-158. doi: 10.1213/01.ANE.0000093225.39866.75.
Results publication: PubMed 26266386Ren C, Chi M, Zhang Y, Zhang Z, Qi F, Liu Z. Dexmedetomidine in Postoperative Analgesia in Patients Undergoing Hysterectomy: A CONSORT-Prospective, Randomized, Controlled Trial. Medicine (Baltimore). 2015 Aug;94(32):e1348. doi: 10.1097/MD.0000000000001348.
Results publication: PubMed 27977073Orbach-Zinger S, Fireman S, Ben-Haroush A, Karoush T, Klein Z, Mazarib N, Artyukh A, Chen R, Ioscovich A, Eidelman LA, Landau R. Preoperative sleep quality predicts postoperative pain after planned caesarean delivery. Eur J Pain. 2017 May;21(5):787-794. doi: 10.1002/ejp.980. Epub 2016 Dec 15.
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Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest (time frame: 6h after cesarean section.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03065530, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.