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

Phase 3

• Conditions: Gastric Cancer
• Interventions: Drug: dexmedetomidine

• Registration Number: NCT03117023
• Lead Sponsor: Nanjing PLA General Hospital

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2017-04
• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-04-14
• Last Update Submitted: 2017-04-14
• Study Start: 2017-04-15
• Study First Posted: 2017-04-17
• Last Update Posted: 2017-04-17
• Primary Completion: 2017-05-15
• Study Completion: 2017-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 -

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine group	dexmedetomidine	sufentanil + dexmedetomidine

Primary Outcome Measures

Name	Time	Method
sleep time	during the first three days after surgery	total sleep time during the first three days after surgery

Secondary Outcome Measures

Name	Time	Method
daily sufentanil consumption	during the first three days after surgery	daily sufentanil consumption
functional recovery	during the first three days after surgery	time to functional recovery
length of hospital stay	during the first three days after surgery	length of hospital stay
pain score	during the first three days after surgery	pain score measure
side effects	during the first three days after surgery	lethargy and mental sluggishness