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

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Sun Yat-sen University

Status

Unknown

Conditions

Intestinal Fistula
Cirrhosis
Aneurism
Abdominal Tumor
Intestinal Obstruction

Treatments

Drug: propofol
Drug: dexmedetomidine

Study type

Observational

Funder types

Other

Identifiers

NCT01669044
IRB[2012]260

Details and patient eligibility

About

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.

Full description

When the patients can be roused, they will first receive analgesia with bolus of fentanyl 0.03mg, followed by a continuous infusion at a fixed dose of 0.3μg/kg/h during study period. Then patients will be randomly divided into two groups (Dexmedetomidine and Propofol). All of them will receive hemodynamic monitoring through "Vigileo"(Edwards Lifesciences) and cardiogram monitor. The study will continue for 6-24 hours.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Postoperative patients of major abdominal surgery
  2. Age ≧ 18

Exclusion criteria

  1. heart rate ≤ 50 bpm
  2. allergy with dexmedetomidine or propofol
  3. pregnancy

Trial design

80 participants in 2 patient groups

dexmedetomidine,hemodynamics,injection
Description:
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.
Treatment:
Drug: dexmedetomidine
propofol,hemodynamics,injection
Description:
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
Treatment:
Drug: propofol

Trial contacts and locations

1

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Central trial contact

mingyin chen, MD

Data sourced from clinicaltrials.gov

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