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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03117023
• Other study ID #: 2017NLY002
• Status: Not yet recruiting
• Phase: Phase 3
• First received: April 12, 2017
• Last updated: April 14, 2017
• Start date: April 15, 2017
• Est. completion date: June 1, 2017

Study information

• Verified date: April 2017
• Source: Nanjing PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 1, 2017
• Est. primary completion date: May 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing PLA General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sleep time	total sleep time during the first three days after surgery	during the first three days after surgery
Secondary	pain score	pain score measure	during the first three days after surgery
Secondary	daily sufentanil consumption	daily sufentanil consumption	during the first three days after surgery
Secondary	functional recovery	time to functional recovery	during the first three days after surgery
Secondary	length of hospital stay	length of hospital stay	during the first three days after surgery
Secondary	side effects	lethargy and mental sluggishness	during the first three days after surgery