The Addition of Dexmedetomidine on Postoperative Sleep for Middle-aged and Elderly Patients With Gastric Cancer

NCT ID: NCT03117023

Last Updated: 2017-04-17

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-15

Study Completion Date

2017-06-01

Brief Summary

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The purpose of this study is to find out the effect of Dexmedetomidine for treatment of sleep deprivation, pain relief and postoperative recovery on middle-aged and elderly Patients with Gastric Cancer.

Detailed Description

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Patients were randomized to receive sufentanil 0.05ug/kh/h + dexmedetomidine 0.1ug/kg/h (DEX group) or sufentanil 0.05ug/kg/h + saline (control group) for 48h. The primary outcome was the total sleep time during the first three days after surgery. The secondary outcomes included pain score, daily sufentanil consumption, time to functional recovery, length of hospital stay and side effects.

Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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dexmedetomidine group

sufentanil + dexmedetomidine

Group Type EXPERIMENTAL

dexmedetomidine

Intervention Type DRUG

sufentanil 0.05ug/kh/h + dexmedetomidine 0.1ug/kg/h for 48h after surgery

control group

sufentanil + saline

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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dexmedetomidine

sufentanil 0.05ug/kh/h + dexmedetomidine 0.1ug/kg/h for 48h after surgery

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Elective gastric cancer operation Age ≧ 55 years ASA classification:I to III, BMI: 18-30 kg/m2 without the history of gastrointestinal surgery the normal coagulation function -

Exclusion Criteria

the history of gastrointestinal surgery Gastrostomy and jejunostomy sleep apnea syndrome or severe osahs Severe liver and heart dysfunction Severe mental illness

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Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gao Tao

Attending

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2017NLY002

Identifier Type: -

Identifier Source: org_study_id

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