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

Chinese Medical Association

Status: Unknown

Conditions: Postoperative Sedation,Gastrectomy, Enhanced Recovery After Surgery

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

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02674737

Jinling37ICUCMH

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Dexmedetomidine,tramadol and flurbiprofen

Experimental group

Description:

Both sedative and analgesic(dexmedetomidine, tramadol and flurbiprofen) are applied to this group of patients.

Treatment:

Drug: dexmedetomidine, tramadol and flurbiprofen

Tramadol and flurbiprofen

Active Comparator group

Description:

Only routine analgesic(tramadol and flurbiprofen) are applied to this group of patients.

Treatment:

Drug: tramadol and flurbiprofen