The efficacy and safety of an adapted opioid-free anesthesia regimen versus conventional general anesthesia in gynecological surgery for low-resource settings: a randomized pilot study

Abstract

Introduction There is scarce data on the safety and efficacy of opioid-free anesthesia (OFA), in resource-limited settings due to the non-availability of dexmedetomidine, the reference OFA agent. We aimed to demonstrate the feasibility, efficacy and safety of a practical OFA protocol not containing dexmedetomidine, adapted for low-resource environments in very painful surgeries like gynecological surgery. Methods We conducted a randomized pilot study on ASA I and II women undergoing elective gynecological surgery at a tertiary care hospital in Cameroon. Patients were matched in a ratio of 1:1 into an OFA and a conventional general anesthesia (CGA) group. The OFA protocol entailed the intravenous (IV) magnesium sulfate, lidocaine, ketamine, dexamethasone, propofol, and rocuronium, followed by isoflurane and a continuous infusion of a calibrated mixture of magnesium sulfate, ketamine and clonidine. The CGA protocol was IV dexamethasone, diazepam, fentanyl, propofol, and rocuronium, followed by isoflurane and reinjections of fentanyl propofol and a continuous infusion of normal saline as placebo. The primary endpoints were the success rate of OFA, isoflurane consumption and intraoperative anesthetic complications. The secondary endpoints were postoperative pain intensity, postoperative complications, patient satisfaction assessed using the QoR-40 questionnaire and the financial cost of anesthesia. Results We enrolled a total of 36 women undergoing gynecological surgery; 18 in the OFA group and 18 in the CGA group. The success rate of OFA was 100% with significant lesser consumption of isoflurane in the OFA group, no significant intraoperative complication and better intraoperative hemodynamic stability in the OFA group. Postoperatively, compared to the CGA group, the OFA group had statistically significantly less pain during the first 24 h, no morphine consumption for pain relief, had less hypoxemia during the first six hours, less paralytic ileus, less nausea and vomiting, no pruritus and better satisfaction. The mean financial cost of this adapted OFA protocol was statistically significant lesser than that of CGA. Conclusion This OFA regimen without dexmedetomidine for a low-resource setting has a promising success rate with few perioperative complications including mild intraoperative hemodynamic changes, decrease postoperative complications, pain, and opioid consumption in patients undergoing elective gynecology surgery. Trial registration This study was registered at clinicaltrials.gov on 03/02/2021 under the registration number NCT04737473.

The Performance of Opioid-Free Anesthesia for Bariatric Surgery in Clinical Practice

“…We planned to observe 50 patients in the OFA group and 50 patients in the OBA group. The number of cases was determined to allow for examining a larger patient collective than had previously been done in smaller randomized studies [2][3][4][5][6]. Normal distribution for continuous data was tested using the Kolmogorov-Smirnov test.…”

“…We observed that 9 (18%) patients in the OBA cohort did not require piritramide. Postoperative opioid consumption (Piritramide) was lower in the OFA group (OFA: 0 [0-3.4], OBA: 6 [3][4][5][6][7][8][9]; P ≤ 0,001). 26 (52%) of 50 patients in the OFA group and 38 (77.6%) of 49 patients in the OBA group received droperidol in the PACU (chi-square test, P = 0.008).…”

“…Opioid-free anesthesia (OFA) has been used for several years in an attempt to reduce risks and to improve recovery after surgery by decreasing opioid-induced side effects. For OFA, opioids are replaced by anesthetic adjuncts, such as ketamine, lidocaine, dexmedetomidine, and magnesium [1][2][3][4][5]. The use of OFA has been investigated for various types of surgery (e.g.…”

Opioid-Free Anesthesia (OFA) as a Safe Anesthetic Choice for Epilepsy Patient

“…Therefore, the post-synaptic inhibitory effect of GABA in the thalamus will be extended. 15 Thiopental also acts on glutamate, adenosine, and nicotinic acetylcholine receptors. 15,16 Anesthesia in this patient was stable, while the patient's hemodynamics were also stable during anesthesia.…”

“…15 Thiopental also acts on glutamate, adenosine, and nicotinic acetylcholine receptors. 15,16 Anesthesia in this patient was stable, while the patient's hemodynamics were also stable during anesthesia. Furthermore, the patient's CONOX score was stable, with qCON in the range of 40-65 and qNOX in the range of 40-60.…”