Physiological effects of drugs
Conditions
Interventions
This is a randomized, controlled, two-arm, single-blind clinical trial, in which only the patient was unaware of which group he belonged to. Continuous infusions of dexmedetomidine or 0.9% saline solu
6 hours after the beginning of the closure of the orifices and the end of the drug or placebo infusion (sample 2, T6)
and the last blood sample was taken by me the morning after the pos
Sponsors
Gustavo Nascimento Silva
Hospital Universitário Gaffree e Guinle
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Patients classified as physical health status 1 and 2; Laparoscopic Cholecystectomy Surgery; Patients who signed the Free and Informed Consent Form
Exclusion criteria
Exclusion criteria: Patients classified as physical health status more than 2 ;Conversion to open surgery;Emergency Surgeries
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected Outcome 1: It is expected to find an anti-inflammatory effect verified by the reduction of the levels of Interleukin 6, from the verification of a variation of at least 5% in the measurements between the control(B) and intervention(A) groups. ;Outcome Found 1: An anti-inflammatory effect verified by the reduction of Interleukin 6 levels was found in group A compared to group B, 4-6 hours after surgery.;Expected Outcome 2: It is expected to find an anti-inflammatory effect verified by the reduction of the levels of C-Reactive Protein, from the verification of a variation of at least 5% in the measurements between the control(B) and intervention(A) groups.;Outcome Found 2: There was an increase in C-Reactive Protein values 4-6 hours after surgery in both groups when compared to baseline values. No anti-inflammatory effect was found for this variable.;Expected Outcome 3: It is expected to find an attenuating effect of the endocrine response verified by the reduction of Cortisol levels, from the verification of a variation of at least 5% in the measurements between the control group (B) and intervention (A).;Outcome Found 3: There was no difference between the groups for the variable cortisol in the postoperative period.;Expected Outcome 4: It is expected to find an attenuating effect of the endocrine response verified by the reduction of the levels of Glycemia, from the verification of a variation of at least 5% in the measurements between the control group (B) and intervention (A).;Outcome Found 4: There was no difference between the groups for the variable Glycemia in the postoperative period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected Outcome 1: It is expected to find a reduction in pain scores of at least 10% in patients who received the intervention at both postoperative times.;Outcome Found 1: A reduction in pain scores was found in the 1st postoperative hour in patients who received the intervention.;Expected Outcome 2: It´s expected to find Lower blood pressure values in the intervention group compared to the control group in the perioperative period. ;Outcome Found 2: Lower blood pressure values were found in the intervention group compared to the control group in the perioperative period.;Expected Outcome 3: It is expected to find lower opioid consumption in the postoperative period of patients who underwent the intervention, with a variation of at least 5%, in relation to the control group.;Outcome Found 3: There was a reduction in opioid consumption in the immediate postoperative period (1 hour after surgery) in the intervention group. ;Expected Outcome 4: It is expected to find a lower incidence of nausea and vomiting in the postoperative period in patients who underwent the intervention, with a variation of at least 5%, in relation to the control group.;Outcome Found 4: There was no difference between groups in the incidence of postoperative nausea and vomiting.;Expected Outcome 5: It is expected to find a better pattern of return to spontaneous ventilation before extubation in all variables, with a 5% variation in their values, in the intervention group.;Outcome Found 5: Higher values of respiratory rate (RR) and peripheral oxygen saturation (SpO2) were found in the intervention group before extubation. ;Expected Outcome 6: It is expected to find lower sedation/agitation scores in the intervention group, with a variation of at least 5%, in relation to the control group, after extubation. ;Outcome Found 6: No differences were found in sedation/agitation scores between groups after extubation. | — |
Countries
Brazil
Contacts
Public ContactGustavo Silva
Hospital Universitário Gaffree e Guinle
Outcome results
None listed