None listed
Conditions
Brief summary
Intraoperative use of loading doses of tramadol-patient control analgesia (PCA) has been recommended in previously published articles. It is recommended mostly due to its diminishing effect on the frequency of postoperative nausea and vomiting (PONV) at Postanesthesia Care Unit (PACU), which is immediately after surgery. There is also a recommendation on the optimal intraoperative loading dose actually by the same authors, which is 2.5 mg.kg-1. We used this recommended optimal dose in our clinic, and we observed that emergence times of our patients prolonged to a duration of more than 40 minutes. We planned this study in order to reduce the need for intraoperative loading dose to a lower dose than 2.5 mg.kg-1. We hypothesized that preoperatively administered analgesics reduce the intraoperative loading dose. Our results revealed that this optimal dose may be reduced to a lower dose, while both providing adequate analgesia with less tramadol-PCA consumption.
Interventions
35-65 year-old, 45 ASA I and II patients, undergoing elective total abdominal hysterectomy (TAH) with or without bilateral salpingo-oopherectomy (BSO) under general anesthesia in Ankara EZH Research and Teaching Hospital, were enrolled (1:1:1) into this prospective, randomized, double-blind study. All patients received 1 mg/kg intravenous (iv) tramadol (infused in 100 ml NS over 15 minutes) and 75 mg intramuscular (im) diclofenac sodium 30 minutes before surgery. The patients were randomized int
35-65 year-old, 45 ASA I and II patients, undergoing elective total abdominal hysterectomy (TAH) with or without bilateral salpingo-oopherectomy (BSO) under general anesthesia in Ankara EZH Research and Teaching Hospital, were enrolled (1:1:1) into this prospective, randomized, double-blind study. All patients received 1 mg/kg intravenous (iv) tramadol (infused in 100 ml NS over 15 minutes) and 75 mg intramuscular (im) diclofenac sodium 30 minutes before surgery. The patients were randomized into three groups (using computer-generated random numbers list with codes in sealed envelopes) to receive either placebo (Group I), 0.5 mg/kg (Group II) or 1 mg/kg (Group III) iv tramadol at the begining of the fascia closure, about 30 minutes before the end of surgery. The different doses of tramadol, prepared and labeled according to codes, were in equal volume syringes (in normal saline). Our hypothesis was ‘iv tramadol combined with im diclofenac sodium administered 30 minutes before the operation, reduces intraoperative loading dose’.
Sponsors
Turkish Ministery of Health Ankara Etlik ZH Maternity and Women’s Health Research and Teaching Hospital, Ankara, Turkey
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
35 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Elective Total Abdominal Hysterctomy with or without BSO under general anesthesia
Exclusion criteria
Known allergy, sensitivity or contraindications to study drugs, inability to use PCA device, long-term use of opioid medications, use of any analgesic drugs in the last 24 hours, history of clinically significant cardiac, respiratory, hepatic or renal disease and history of chronic pain and previous history of postoperative nausea and vomiting.
Outcome results
None listed