Obesity
Conditions
Interventions
After clarification and obtaining consent, patients eligible to participate in the study were allocated to one of two groups: Group
Remi (received remifentanil) n = 40, or Dex-Fenta Group (received de
Drug
D03.383.621.265
D27.505.696.663.700
Sponsors
Santa Casa de Misericórida de Belo Horizonte
Hospital São José do Avaí
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Patients sequentially scheduled for Roux-en-Y Reduction Gastroplasty; age between 18 and 70 years; agreement and signature of the free and informed consent term.
Exclusion criteria
Exclusion criteria: Chronic use of opioids; patients with chronic pain; history of chemical dependence; allergic to any of the medications used in the study; patients with any cardiac, respiratory, renal or hepatic pathology that is considered severe.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome expected: Reduction of postoperative pain in the group 2 DEX-FENTA compared to the REMI group, evaluated by the 11-point verbal pain scale (0 to 10). Evaluations performed after 1, 4 and 24 hours after the surgery.;Primary outcome observed: During the first hour after the procedure patients in Group 2 DEX-FENTA showed a lower pain score in comparison with those in Group 1 REMI (p<0.05). Pain scale score evaluations 4 and 24 hours after the procedure were similar in both groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome expected: Reduction of morphine consumption in the postoperative period of patients in group 2 DEX-FENTA compared to group 1 REMI. Assessment in the postoperative recovery room and in the first 24 hours after the end of the surgery. ;Secondary outcome observed: Morphine consumption was equivalent in the comparison between the two study groups;Expected secondary outcome: higher incidence of mean arterial hypotension and bradycardia in group 2 DEX-FENTA compared to group 1 REMI in the intra and postoperative periods. Measurements were made from initiation of study drug infusion (beginning of anesthesia) at intervals of 2.5 minutes to orotracheal intubation, 5-minute intervals from orotracheal intubation to orotracheal extubation, and at 15-minute intervals in the post-anesthetic recovery. ;Secondary outcome observed: There was a higher incidence of mean arterial hypotension in group 2 DEX-FENTA compared to group 1 REMI in some intraoperative periods (p <0.05, effect size = -0.7694) but not in the postoperative period. There was no difference between the groups regarding the incidence of bradycardia. ;Expected secondary outcome: Reduction of postoperative nausea and vomiting in group 2 DEX-FENTA as compared to group 1 REMI evaluated by the 4-point verbal scale (1- no nausea 2- slight nausea 3- moderate nausea 4- intense nausea). Evaluations performed after 1, 4 and 24 hours after the surgery. ;Secondary outcome observed: the intensity of postoperative nausea and vomiting was similar in the two study groups.;xpected secondary outcome: Postoperative sedation levels measured by the similar Ramsay scale in the two groups Ramsay Scale 1- Shaken 2- Cooperative, calm 3- Sleepy, responsive to verbal commands 4- Sleeping, responsive to vigorous verbal stimulation or slight touch on the glabella 5- Sleeping, responsive with mild allergic stimulation. 6- Sleeping unresponsive to allergic stimulation (glabellar compression) Evaluations performed | — |
Countries
Brazil
Contacts
Public ContactRafael Abud
Santa Casa de Misericórida de Belo Horizonte
Outcome results
None listed