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 co...
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| Format: | Article |
| Language: | English |
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BMC
2022-10-01
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| Series: | BMC Anesthesiology |
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| Online Access: | https://doi.org/10.1186/s12871-022-01856-6 |
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| author | Joel Noutakdie Tochie Roddy Stephan Bengono Bengono Junette Mbengono Metogo Raymond Ndikontar Serges Ngouatna Ferdinand Ndom Ntock Jacqueline Ze Minkande |
| author_facet | Joel Noutakdie Tochie Roddy Stephan Bengono Bengono Junette Mbengono Metogo Raymond Ndikontar Serges Ngouatna Ferdinand Ndom Ntock Jacqueline Ze Minkande |
| author_sort | Joel Noutakdie Tochie |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-12T01:25:51Z |
| format | Article |
| id | doaj.art-ea578c9b2fc7437eb36344359a0e71ee |
| institution | Directory Open Access Journal |
| issn | 1471-2253 |
| language | English |
| last_indexed | 2024-04-12T01:25:51Z |
| publishDate | 2022-10-01 |
| publisher | BMC |
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| series | BMC Anesthesiology |
| spelling | doaj.art-ea578c9b2fc7437eb36344359a0e71ee2022-12-22T03:53:39ZengBMCBMC Anesthesiology1471-22532022-10-0122111310.1186/s12871-022-01856-6The efficacy and safety of an adapted opioid-free anesthesia regimen versus conventional general anesthesia in gynecological surgery for low-resource settings: a randomized pilot studyJoel Noutakdie Tochie0Roddy Stephan Bengono Bengono1Junette Mbengono Metogo2Raymond Ndikontar3Serges Ngouatna4Ferdinand Ndom Ntock5Jacqueline Ze Minkande6Department of Surgery and Sub-Specialties, Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1Department of Surgery and Sub-Specialties, Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1Department of Surgery and Sub-Specialties, Faculty of Medicine and Pharmaceutical Sciences, University of DoualaDepartment of Surgery and Sub-Specialties, Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1Department of Surgery and Sub-Specialties, Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1Department of Surgery and Sub-Specialties, Faculty of Medicine and Pharmaceutical Sciences, University of DoualaDepartment of Surgery and Sub-Specialties, Faculty of Medicine and Biomedical Sciences, University of Yaoundé 1Abstract 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.https://doi.org/10.1186/s12871-022-01856-6Opioid-free anesthesiaAdaptedGynecological surgeryEfficacySafetyCameroon |
| spellingShingle | Joel Noutakdie Tochie Roddy Stephan Bengono Bengono Junette Mbengono Metogo Raymond Ndikontar Serges Ngouatna Ferdinand Ndom Ntock Jacqueline Ze Minkande 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 BMC Anesthesiology Opioid-free anesthesia Adapted Gynecological surgery Efficacy Safety Cameroon |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Opioid-free anesthesia Adapted Gynecological surgery Efficacy Safety Cameroon |
| url | https://doi.org/10.1186/s12871-022-01856-6 |
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