The research to take the oral tablet morphine sulphate for preoperative under general anesthesia: to postoprative pain and sedation

UMIN ID: UMIN000028193

Registered date:12/07/2017

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: We intend for ASA PS 1-2 from 20-80years old having anoperation of limbs among orthopedics patients
• Date of first enrollment: 2006/11/24
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Study group: 60 mg of sustained-release morphine sulfate administered orally at 90 to 120 minutes before introduction of general anesthesia. Then I went to the operating room. General anesthesia is 1% propofol (1 mg / kg) with introduction drug, sevoflurane, nitrous oxide, oxygen (oxygen concentration in the circuit 50%) for maintenance. The concentration of sevoflurane in the intraoperative carburetor will be set appropriately according to the situation of anesthesia and surgery. After that, we perform fundamental perioperative management and at the same time conduct surveys to be described later. investigation: Analgesia: Study using visual analog scale (VAS) score face scale (part diverted) immediately after returning home (4-6 hours after oral administration) and blood collection after returning (12-18 hours after oral administration) .In addition, 50 mg intravenous flurbiprofen (Flurbiprofen) as an analgesic, intramuscular injection of 30 mg pentazocine + 50 mg hydroxyzine (Hydroxyzine), 50 mg dose of diclofenac sodium (Diclofenac) according to the degree of analgesia. The use standard was VAS 50 mm or more. Also investigate the use of analgesics. Sedation: Investigate using Ramsay sedation score (RSS) after oral administration, 2 hours, 4-6 hours, 12-18 hours. and Investigation of circulatory dynamics during operation: (blood pressure, heart rate) etc. And Morphine blood concentration is collected (at least twice) in 2, 4-6 and 12-18 hours after premedication. The intervention period was up to 24 hours after drug oral. In addition, when side effects appear, appropriate drug administration and treatment corresponding to symptoms should be carried out.
Comparative control group: 5-7 mg of diazepam orally administered 90 to 120 minutes before introduction of general anesthesia. Then I went to the operating room. In the control group. No blood was drawn. Other general anesthesia management, postoperative analgesia, evaluation of sedation, and analgesic treatment were performed in the same manner as in the survey group.

Outcome(s)

• Primary Outcome: Postoperative pain and side effects for oral tablet morphine sulfate are mainly determined around 4-6,18-24 hours after oral. For postoperative pain relief, use of analgesic drugs as a main index.And we also visited patients up to 3 days postoperatively, including confirmation of side effects.
• Secondary Outcome: Key secondary outcomes for postoperativepain,and sedation :Postoperativepain are determined VAS scale, and diverted part of face scale. For sedation, use the Ramsay sedation score (RSS). In addition, measure the blood concentration at the perioperative period from some patients, and use it as a reference index of the drug effect.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: We excluded those less than ASA physical status and non-cooperative in research.

Related Information

• Primary Sponsor: Tokyo women's medical university medical hospital
• Source(s) of Monetary Support: Tokyo women's medical university medical hospital