Evaluation of the Effect of Appropriate Sedation for Patients After Gastrectomy: A Prospective Randomised Controlled Study

To evaluate the efficacy and safety of appropriate postoperative sedation with dexmedetomidine for patients after gastrectomy. Prospective randomised controlled study was conducted from October 2015 and December 2015 among patients after gastrectomy. The investigators are going to enroll patients who received abdominal surgeries. One group receive sedative along with analgesic and the other group analgesic only for the other group on the first 24 hours after surgeries and follow up for 3 days.

Study Overview

• Status: Unknown
• Conditions: Postoperative Sedation,Gastrectomy, Enhanced Recovery After Surgery
• Intervention / Treatment: Drug: tramadol and flurbiprofen; Drug: dexmedetomidine, tramadol and flurbiprofen

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Minhua Cheng, M.D.; Phone Number: 15951813384; Email: cmhnju@163.com
• Study Contact Backup: Name: Wenkui Yu, Ph.D.; Phone Number: 13701582986; Email: yudrnj@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Recruiting
      • Institute of General Surgery of Jinling Hospital
      • Contact: Wenkui Yu, Ph.D.; Phone Number: 13701582986; Email: yudrnj@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18-85 years old
• underwent gastrectomy in the hospital and operation duration lasted at least 2 hours

Exclusion Criteria:

• take part in other clinical trials
• quinolone antibiotics intake 4 weeks prior to or within the study
• NSAIDS intake within one month
• history of peptic ulcer
• respiratory insufficiency
• renal insufficiency
• acute hepatitis or severe liver disease (Child-Pugh class C)
• pregnancy or lactation
• abnormal ECG with clinical significance
• uncontrolled hypotension
• bleeding tendency or hematological diseases
• untreated mechanical intestinal obstruction
• unable to express or any kind of mental disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine,tramadol and flurbiprofen; Both sedative and analgesic(dexmedetomidine, tramadol and flurbiprofen) are applied to this group of patients.	Drug: dexmedetomidine, tramadol and flurbiprofen
Active Comparator: Tramadol and flurbiprofen; Only routine analgesic(tramadol and flurbiprofen) are applied to this group of patients.	Drug: tramadol and flurbiprofen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain assessed by Prince Henry Pain Scale	assessed by Prince Henry Pain Scale by investigators at 8:00 am after surgeries until discharge from ICU	1-3d after gastrectomy
recovery of gastrointestinal function assessed by time to first defecation after surgery	assessed by time to first defecation after surgery	30 days after gastrectomy
white blood cell count (10^9/L)	evaluate postoperative inflammatory response, blood sample collected at 6:00am for 1-3d after gastrectomy	1-3d after gastrectomy
C-reactive protein (mg/L)	evaluate postoperative inflammatory response, blood sample collected at 6:00am for 1-3d after gastrectomy	1-3d after gastrectomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of time within target sedation range	assessed by Richmond Agitation-Sedation Scale by investigators at 8:00 am after surgeries until discharge from ICU, the target range is -2 to +1	1-3d after gastrectomy
risk of bradycardia requiring interventions	heart rate <40/min is considered bradycardia	1-3d after gastrectomy
risk of hypotension requiring interventions	systolic blood pressure <80 mmHg or/and diastolic blood pressure <50 mmHg is considered hypotension	1-3d after gastrectomy
use of opioids and use of benzodiazepins		1-3d after gastrectomy

Collaborators and Investigators

• Sponsor: Chinese Medical Association

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): May 1, 2016

Study Registration Dates

• First Submitted: January 21, 2016
• First Submitted That Met QC Criteria: February 3, 2016
• First Posted (Estimate): February 4, 2016

Study Record Updates

• Last Update Posted (Estimate): February 4, 2016
• Last Update Submitted That Met QC Criteria: February 3, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Dexmedetomidine; Tramadol; Flurbiprofen
• Other Study ID Numbers: Jinling37ICUCMH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Main results and conclusion will be available