Comparison the Hemodynamics Effects Between Dexmedetomidine and Propofol in Major Abdominal Surgical Patients

NCT01669044 | Unknown DMC

• 1 other identifier: IRB[2012]260
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The alpha2 agonist dexmedetomidine is a new sedative agent combined with the analgesic qualities and lack of respiratory depression. Patients sedated with dexmedetomidine could be easily roused, these advances shows dexmedetomidine may be a effective and safe sedative agent. But some studies showed some adversely effects of dexmedetomidine on haemodynamics (such as bradycardia, hypotension), the investigators want to further research the effects of dexmedetomidine on haemodynamics, such as Cardiac Output (CO), Systemic Venous Resistance Index(SVRI), and so on. Propofol is widely used sedative agent in ICU, it also has adversely effects like bradycardia and hypotension, so the investigators want to compare the effect of dexmedetomidine with propofol on haemodynamics after major abdominal surgery. Expect to further research the mechanism of haemodynamics of dexmedetomidine.

Conditions

Abdominal Tumor; Intestinal Obstruction; Cirrhosis; Intestinal Fistula; Aneurism

Outcome Measures

Primary Outcomes (1)

• Cardiac output

  the study will start when the patient can be roused after major abdominal surgery and will continue for 6 to 24hours

Secondary Outcomes (1)

• Stroke Volume

  the study will start when the patient can be roused after major abdominal surgery and will continue for 6 to 24hours

Other Outcomes (1)

• Systemic Venous Resistance Index

  the study will start when the patient can be roused after major abdominal surgery and will continue for 6 to 24hours

Study Arms (2)

dexmedetomidine,hemodynamics,injection

Group 1:when the patient can be roused after major abdominal surgery ，we will inject dexmedetomidine at 1μg/kg in 10 minutes as a loading dose, followed by a continuous infusion at 0.3μg/kg/h for 6 to 24hours.then adjust the infusion dose to maintain the ramsay scale at 3-4 scores.

Drug: dexmedetomidine

propofol,hemodynamics,injection

Group 2 :when the patient can be roused after major abdominal surgery ，we will inject propofol at 0.5mg/kg as a loading dose, followed by a continuous infusion at 0.5mg/kg.h for 6 to 24hours.then adjust the infusion dose to maintain the ramsay scale at 3-4 scores

Drug: propofol

Interventions

dexmedetomidine DRUG

dexmedetomidine: IV (in the vein)at 1μg/kg in 10 minutes as a loading dose, followed by a continuous infusion at 0.3μg/kg/h.then adjust the infusion dose to maintain the ramsay scale at 3-4 scores.

dexmedetomidine,hemodynamics,injection

propofol DRUG

propofol: IV (in the vein)at 0.5mg/kg as a loading dose, followed by a continuous infusion at 0.5mg/kg/h.then adjust the infusion dose to maintain the ramsay scale at 3-4 scores.

propofol,hemodynamics,injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Postoperative patients of major abdominal surgery

You may qualify if:

• Postoperative patients of major abdominal surgery
• Age ≧ 18

You may not qualify if:

• heart rate ≤ 50 bpm
• allergy with dexmedetomidine or propofol
• pregnancy

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

First affiliated hostipal,Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Abdominal Neoplasms; Intestinal Obstruction; Fibrosis; Intestinal Fistula

Interventions

Dexmedetomidine; Propofol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Fistula; Fistula; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• minying chen, MD

  study principal investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mingyin chen, MD

CONTACT

008613925019136; chmy1969@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 16, 2012
• First Posted: August 20, 2012
• Study Start: May 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 22, 2012

Record last verified: 2012-08

Locations

CN (1)