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

April 14, 2017 updated by: Gao Tao, Nanjing PLA General Hospital

The Addition of Dexmedetomidine on Postoperative Sleep for Middle-aged and Elderly Patients With Gastric Cancer: A Prospective Randomized Clinical Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dexmedetomidine group
sufentanil + dexmedetomidine
Drug: dexmedetomidine
sufentanil 0.05ug/kh/h + dexmedetomidine 0.1ug/kg/h for 48h after surgery
No Intervention: control group
sufentanil + saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sleep time
Time Frame: during the first three days after surgery
total sleep time during the first three days after surgery
during the first three days after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 15, 2017

Primary Completion (Anticipated)

May 15, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

April 12, 2017

First Submitted That Met QC Criteria

April 14, 2017

First Posted (Actual)

April 17, 2017

Study Record Updates

Last Update Posted (Actual)

April 17, 2017

Last Update Submitted That Met QC Criteria

April 14, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017NLY002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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