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

Chinese Medical Association

Status: Completed

Conditions: Postoperative Sedation, Abdominal Surgery

Treatments: Drug: Dexmedetomidine, tramadol and flurbiprofen; Drug: tramadol and flurbiprofen

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02670954

Jinling37ICU

Details and patient eligibility

About

To evaluate the efficacy and safety of appropriate postoperative sedation with dexmedetomidine for patients after abdominal surgeries.Prospective randomised controlled study was conducted among patients after abdominal surgeries began in October 2015.The investigators 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 will follow up for 3 days.

Enrollment: 154 patients

Sex: All

Ages: 16 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• 16-85 years old
• underwent abdominal surgeries including enterectomy, gastrectomy, hepatectomy and pancreatectomy 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 2 patient groups

Dexmedetomidine,tramadol and flurbiprofen

Experimental group

Description:

Both routine analgesic and sedation(dexmedetomidine,tramadol and flurbiprofen) are applied for this group of patients.

Treatment:

Drug: Dexmedetomidine, tramadol and flurbiprofen

Tramadol and flurbiprofen

Active Comparator group

Description:

Only routine analgesic(Tramadol and flurbiprofen) is applied for this group of patients.

Treatment:

Drug: tramadol and flurbiprofen