Effect of Immunological Reactions of Dexmedetomidine when used in patients undergoing Video-Assisted Gallbladder Removal

Phase 2

• Conditions: Physiological effects of drugs; Y57.8

• Registration Number: RBR-2rgxbdv
• Lead Sponsor: Gustavo Nascimento Silva

Brief Summary

Background: Laparoscopy is a revolution of digital and robotic technology for surgical practice, and gallstones are responsible for over 700,000 cases of cholecystectomies annually in the United States. Pneumoperitoneum is vital in safe laparoscopic surgery, but the repercussions of ischemia-reperfusion and aseptic trauma compromise the return of physiologic functions. Associating dexmedetomidine with general anesthesia promotes the control of the response to trauma by altering the neuroinflammatory reflex, providing better clinical outcomes in the postoperative period and reducing the excessive use of drugs with risk for addiction. This trial aims to evaluate the therapeutic and immunomodulatory potential of dexmedetomidine on perioperative organ function in a medium-sized surgical model. Methods: We standardized two groups: Sevoflurane and Dexmedetomidine - A (26 patients) vs Sevoflurane and Saline 0.9% - B (26 patients). Three blood samples were collected at three times (T): T0h before surgery, T4-6h after surgery and T24h postoperatively. The dosage of inflammatory and endocrine mediators were protocolized for analysis. Finally, hemodynamic outcomes, quality upon awakening, pain, postoperative nausea and vomiting and opioid use were compared between groups. Results: After reproducing the aseptic trauma model and reaching the sample, a reduction of Interleukin 6 was found during 4-6 hours after surgery in A group: 34.10 (IQR 13.88 - 56.15) vs 65.79 (IQR 23.13 - 104.97; p = 0.0425) in B group. Systolic blood pressure, diastolic blood pressure and mean arterial pressure were attenuated in A group in their measurement intervals (p< 0.0001). There was a lower incidence of pain and opioid consumption in the first postoperative hour favoring A group (p<0.0001). We noticed better quality upon awakening after the intervention when comparing the values of peripheral oxygen saturation and respiratory rate. Conclusions: Dexmedetomidine provided anti-inflammatory activity, sympatholytic effect and analgesia with respiratory safety. It becomes a horizon for studies focusing on organ protection, hospital cost reduction and pharmacoeconomics.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-28
• Study Completion: 2022-10-31
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Not specified
• Target Recruitment: Not specified

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

Patients classified as physical health status more than 2 ;Conversion to open surgery;Emergency Surgeries

Study & Design

• Study Type: Intervention
• Study Design: Not specified