NCT02316236

Brief Summary

The study is to observe whether dexmedetomidine could reduce agitation during emergence from general anesthesia in patients undergoing retroperitoneal laparoscopic surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

December 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2015

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2015

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

8 months

First QC Date

December 8, 2014

Last Update Submit

May 25, 2022

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Richmond Score

    From end of sevoflurane inhalation to departure from PACU, an expected average of 1 hour

Secondary Outcomes (2)

  • Cough score

    From end of sevoflurane inhalation to departure from PACU, an expected average of 1 hour

  • Time to awake

    From end of sevoflurane inhalation to departure from PACU, an expected average of 1 hour

Study Arms (2)

dexmedetomidine loading dose

EXPERIMENTAL

dexmedetomidine is given at load dose

Drug: dexmedetomidineOther: loading dose

dexmedetomidine sustaining dose

EXPERIMENTAL

dexmedetomidine is given at sustaining dose

Drug: dexmedetomidineOther: sustaining dose

Interventions

dexmedetomidineDRUG

an alpha-2 receptor agonist

Also known as: dex
dexmedetomidine loading dosedexmedetomidine sustaining dose
loading doseOTHER

0.8ug/kg of dexmedetomidine is given in 10 minutes

Also known as: LD
dexmedetomidine loading dose
sustaining doseOTHER

0.4ug/kg/min of dexmedetomidine is given

Also known as: SD
dexmedetomidine sustaining dose

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for retroperitoneal laparoscopic surgery
  • Patients with written informed consent

You may not qualify if:

  • Patients with difficulty of communication
  • Patients with risk of obstructive sleeping apnea syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (3)

  • Yang S, Lee H. A dose-finding study of preoperative intravenous dexmedetomidine in children's emergence delirium after epiblepharon surgery. Eur J Ophthalmol. 2014 May-Jun;24(3):417-23. doi: 10.5301/ejo.5000396. Epub 2013 Nov 29.

    PMID: 24338578RESULT

  • Kim SY, Kim JM, Lee JH, Song BM, Koo BN. Efficacy of intraoperative dexmedetomidine infusion on emergence agitation and quality of recovery after nasal surgery. Br J Anaesth. 2013 Aug;111(2):222-8. doi: 10.1093/bja/aet056. Epub 2013 Mar 22.

    PMID: 23524149RESULT

  • Ibacache ME, Munoz HR, Brandes V, Morales AL. Single-dose dexmedetomidine reduces agitation after sevoflurane anesthesia in children. Anesth Analg. 2004 Jan;98(1):60-63. doi: 10.1213/01.ANE.0000094947.20838.8E.

    PMID: 14693585RESULT

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Lize Xiong, PhD

    Air Force Military Medical University, China

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 8, 2014

First Posted

December 12, 2014

Study Start

December 10, 2014

Primary Completion

August 12, 2015

Study Completion

August 13, 2015

Last Updated

May 26, 2022

Record last verified: 2022-05

Locations

CN(1)