Dexmedetomidine to Improve Outcomes During Emergence From Retroperitoneal Laparoscopic Surgery

NCT ID: NCT02316236

Last Updated: 2022-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-10

Study Completion Date

2015-08-13

Brief Summary

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

Detailed Description

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Agitation during emergence is frequent after retroperitoneal urologic surgery. Dexmedetomidine is alpha-2 receptor agonist which shows sedative and algesic effect. In this study we will compare the effect of dexmedetomidine given by different protocols on emergence agitation.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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dexmedetomidine loading dose

dexmedetomidine is given at load dose

Group Type EXPERIMENTAL

dexmedetomidine

Intervention Type DRUG

an alpha-2 receptor agonist

loading dose

Intervention Type OTHER

0.8ug/kg of dexmedetomidine is given in 10 minutes

dexmedetomidine sustaining dose

dexmedetomidine is given at sustaining dose

Group Type EXPERIMENTAL

dexmedetomidine

Intervention Type DRUG

an alpha-2 receptor agonist

sustaining dose

Intervention Type OTHER

0.4ug/kg/min of dexmedetomidine is given

Interventions

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dexmedetomidine

an alpha-2 receptor agonist

Intervention Type DRUG

loading dose

0.8ug/kg of dexmedetomidine is given in 10 minutes

Intervention Type OTHER

sustaining dose

0.4ug/kg/min of dexmedetomidine is given

Intervention Type OTHER

Other Intervention Names

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dex LD SD

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients with difficulty of communication
* Patients with risk of obstructive sleeping apnea syndrome
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Zhihong LU

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lize Xiong, PhD

Role: STUDY_CHAIR

Air Force Military Medical University, China

Locations

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Xijing Hospital

Xi'an, Shaanxi, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 24338578 (View on PubMed)

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.

Reference Type RESULT
PMID: 23524149 (View on PubMed)

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.

Reference Type RESULT
PMID: 14693585 (View on PubMed)

Other Identifiers

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XJH-A-2014-6-22-01

Identifier Type: -

Identifier Source: org_study_id

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