scholarly journals The effect of opioid-free anesthesia on the quality of recovery after gynecological laparoscopy: study protocol for a prospective randomized controlled trial

2020 ◽  
Author(s):  
Jae Yen Song ◽  
Hoon Choi ◽  
Minsuk Chae ◽  
Jemin Ko ◽  
Youg Eun Moon

Abstract Background: Because of the indiscriminate use of opioids during the perioperative period, opioid-free anesthesia (OFA) has been increasingly required. Nevertheless, the studies on the detailed techniques and effects of OFA are not sufficient. The Quality of Recovery-40 (QoR-40) questionnaire is a validated assessment tool for measuring recovery from general anesthesia. However, no study has used the QoR-40 to determine if OFA leads to better recovery than standard general anesthesia. Therefore, we aim to perform this study to determine the effects of OFA using dexmedetomidine and lidocaine on the quality of recovery as well as the various postoperative outcomes. Methods: The participants (n=78) will be allocated to one of the two groups; Study group will receive bolus and infusion of dexmedetomidine and lidocaine and Control group will receive remifentanil infusion during general anesthesia for gynecological laparoscopy. The other processes including anesthetic and postoperative care will be performed similarly in two groups. Intraoperative hemodynamic, anesthetic, and nociceptive variables will be recorded. Postoperative outcomes such as QoR-40, pain severity, opioid-related side effects will be assessed. Additionally, ancillary cytokine study (inflammatory cytokine, stress hormone, and reactive oxygen species) will be performed during study period. Discussion: This will be the first study to determine the effect of OFA, using the combination of dexmedetomidine and lidocaine, on the quality of recovery after gynecological laparoscopy compared with standard general anesthesia using remifentanil. The findings from this study will provide scientific and clinical evidence on the efficacy of OFA.Trial registration: ClinicalTrials.gov: NCT04409964. Registered on 28 May 2020.

2020 ◽  
Author(s):  
Jae Yen Song ◽  
Hoon Choi ◽  
Minsuk Chae ◽  
Jemin Ko ◽  
Youg Eun Moon

Abstract Background: Because of the indiscriminate use of opioids during the perioperative period, opioid-free anesthesia (OFA) has been increasingly required. Nevertheless, the studies on the detailed techniques and effects of OFA are not sufficient. The Quality of Recovery-40 (QoR-40) questionnaire is a validated assessment tool for measuring recovery from general anesthesia. However, no study has used the QoR-40 to determine if OFA leads to better recovery than standard general anesthesia. Therefore, we aim to perform this study to determine the effects of OFA using dexmedetomidine and lidocaine on the quality of recovery as well as the various postoperative outcomes. Methods: The patients (n=78) will be allocated to one of the two groups; Study group will receive bolus and infusion of dexmedetomidine and lidocaine and Control group will receive remifentanil infusion during general anesthesia for gynecological laparoscopy. The other processes including anesthetic and postoperative care will be performed similarly in two groups. Intraoperative hemodynamic, anesthetic, and nociceptive variables will be recorded. Postoperative outcomes such as QoR-40, pain severity, opioid-related side effects will be assessed. Additionally, ancillary cytokine study (inflammatory cytokine, stress hormone, and reactive oxygen species) will be performed during study period. Discussion: This will be the first study to determine the effect of OFA, using the combination of dexmedetomidine and lidocaine, on the quality of recovery after gynecological laparoscopy compared with standard general anesthesia using remifentanil. The findings from this study will provide scientific and clinical evidence on the efficacy of OFA.


2021 ◽  
Author(s):  
Jae Yen Song ◽  
Hoon Choi ◽  
Minsuk Chae ◽  
Jemin Ko ◽  
Youg Eun Moon

Abstract Background: Because of the indiscriminate use of opioids during the perioperative period, opioid-free anesthesia (OFA) has been increasingly required. Nevertheless, the studies on the detailed techniques and effects of OFA are not sufficient. The Quality of Recovery-40 (QoR-40) questionnaire is a validated assessment tool for measuring recovery from general anesthesia. However, no study has used the QoR-40 to determine if OFA leads to better recovery than standard general anesthesia. Therefore, we aim to perform this study to determine the effects of OFA using dexmedetomidine and lidocaine on the quality of recovery as well as the various postoperative outcomes. Methods: The participants (n=78) will be allocated to one of the two groups; Study group will receive bolus and infusion of dexmedetomidine and lidocaine and Control group will receive remifentanil infusion during general anesthesia for gynecological laparoscopy. The other processes including anesthetic and postoperative care will be performed similarly in two groups. Intraoperative hemodynamic, anesthetic, and nociceptive variables will be recorded. Postoperative outcomes such as QoR-40, pain severity, opioid-related side effects will be assessed. Additionally, ancillary cytokine study (inflammatory cytokine, stress hormone, and reactive oxygen species) will be performed during study period. Discussion: This will be the first study to determine the effect of OFA, using the combination of dexmedetomidine and lidocaine, on the quality of recovery after gynecological laparoscopy compared with standard general anesthesia using remifentanil. The findings from this study will provide scientific and clinical evidence on the efficacy of OFA.Trial registration: ClinicalTrials.gov: NCT04409964. Registered on 28 May 2020.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jae Yen Song ◽  
Hoon Choi ◽  
Minsuk Chae ◽  
Jemin Ko ◽  
Young Eun Moon

Abstract Background Because of the indiscriminate use of opioids during the perioperative period, opioid-free anesthesia (OFA) has been increasingly required. Nevertheless, the studies on the detailed techniques and effects of OFA are not sufficient. The Quality of Recovery-40 (QoR-40) questionnaire is a validated assessment tool for measuring recovery from general anesthesia. However, no study has used the QoR-40 to determine if OFA leads to better recovery than standard general anesthesia. Therefore, we aim to perform this study to determine the effects of OFA using dexmedetomidine and lidocaine on the quality of recovery as well as the various postoperative outcomes. Methods The participants (n = 78) will be allocated to one of the two groups; the study group will receive bolus and infusion of dexmedetomidine and lidocaine, and the control group will receive remifentanil infusion during general anesthesia for gynecological laparoscopy. The other processes including anesthetic and postoperative care will be performed similarly in the two groups. Intraoperative hemodynamic, anesthetic, and nociceptive variables will be recorded. Postoperative outcomes such as QoR-40, pain severity, and opioid-related side effects will be assessed. Additionally, an ancillary cytokine study (inflammatory cytokine, stress hormone, and reactive oxygen species) will be performed during the study period. Discussion This will be the first study to determine the effect of OFA, using the combination of dexmedetomidine and lidocaine, on the quality of recovery after gynecological laparoscopy compared with standard general anesthesia using remifentanil. The findings from this study will provide scientific and clinical evidence on the efficacy of OFA. Trial registration ClinicalTrials.gov NCT04409964. Registered on 28 May 2020


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Roya Rahimi ◽  
Shirin Hasanpour ◽  
Mojgan. Mirghafourvand ◽  
Khalil Esmaeilpour

Abstract Background Considering the prevalence of infertility in the community and the consequences of failure of infertility treatments on women’s mental health, interventions that can control stress, anxiety and depression in infertile women with a history of IVF failure will be very helpful. This study aimed to determine the effects of hope-oriented group counseling on mental health (primary outcome) and quality of life (QoL) (secondary outcome) of women with failed IVF cycles. Method This randomized controlled trial was conducted on 60 women with failed IVF cycles visiting Infertility Clinic at Al-Zahra Teaching Hospital of Tabriz- Iran. Participants were allocated to the intervention group (n = 30) and control group (n = 30) based on a randomized block design. Hope-oriented group counseling was provided to the intervention group in six 45–60 min sessions (once a week). The control group only received routine care to undergo another IVF cycle. The Depression Anxiety Stress Scale-21 (DASS-21) and the SF-12 Quality of Life Scale were filled out by interviewing the participants before the intervention and one week and one month after the intervention. After intervention 26 participants in each group were included in the analysis. Results There was no significant difference between the intervention and control groups in the socio-demographic profile of participants (P > 0.05). The post-intervention mean score of stress (adjusted mean difference = − 1.7, 95% confidence interval: − 3.2 to − 0.3, P = 0.018) and depression (adjusted mean difference = − 1.3, 95% confidence interval: − 4.7 to − 1.5, P < 0.001) was significantly lower in the intervention group compared to the control. Although the mean anxiety score was lower in the intervention group compared to the control, the difference between them was not statistically significant (adjusted mean difference = − 1.1, 95% confidence interval: − 2.6 to 0.4, P = 0.153). The mean score of QoL was significantly higher in the intervention group than that of the control group (adjusted mean difference = 6.9, 95% confidence interval: 5.1 to 8.8, P < 0.001). Conclusion Hope-oriented group counseling was effective in reducing stress and depression and improving QoL in women with failed IVF cycles. It is recommended to use this counseling approach, along with other methods, to improve the mental health of women with failed IVF cycles. Trial registration TCT Registration Number: TCTR 20191017003, registered on October 17, 2019.


2012 ◽  
Vol 27 (2) ◽  
pp. 133-141 ◽  
Author(s):  
Venkatesan Prem ◽  
Ramesh Chandra Sahoo ◽  
Prabha Adhikari

Objective: To compare two breathing exercises (Buteyko and pranayama) with a control group in patients with asthma. Design: Randomized controlled trial. Subjects: One hundred and twenty subjects were randomized to three groups through block randomization. Subjects with an Asthma Quality of Life Questionnaire score <5.5 participated in the study. Setting: Outpatient pulmonary medicine department. Interventions: Subjects in the Buteyko and pranayama groups were trained for 3–5 days and instructed to practise the exercises for 15 minutes twice daily, and for three months duration. The control group underwent routine pharmacological management during the study period. Outcome measures: Asthma Quality of Life Questionnaire, Asthma Control Questionnaire and pulmonary function test. Results: The baseline characteristics were similar in all three groups. Post intervention, the Buteyko group showed better trends of improvement (mean (95% confidence interval), P-value) in total Asthma Quality of Life Questionnaire score than the pranayama (0.47 (–0.008–0.95), P = 0.056) and control groups (0.97 (0.48–1.46), P = 0.0001). In comparison between the pranayama and control groups, pranayama showed significant improvement (0.50 (0.01–0.98), P = 0.042) in total Asthma Quality of Life Questionnaire score. Conclusion: The Buteyko group showed better trends of improvement in quality of life and asthma control than the group performing the pranayama breathing exercise.


Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Xiangdi Yu ◽  
Fangxiang Zhang ◽  
Bingning Chen

Abstract Introduction In current study we assessed the effect of transcutaneous electrical acupoint stimulation (TEAS) on the quality of early recovery in patients undergoing gynecological laparoscopic surgery. Methods Sixty patients undergoing gynecological laparoscopic surgery were randomly assigned to TEAS (TEAS group) or control group (Con group). TEAS consisted of 30 min of stimulation (12–15 mA, 2/100 Hz) at the acupoints of Baihui (GV20), Yingtang (EX-HN-3), Zusanli (ST36) and Neiguan (PC6) before anesthesia. The patients in the Con group had the electrodes applied, but received no stimulation. Quality of recovery was assessed using a 40-item questionnaire as a measure of quality of recovery (QoR-40; maximum score 200) scoring system performed on preoperative day 1 (T0), postoperative day 1 (T1) and postoperative day 2 (T2); 100-mm visual analogue scale (VAS) scores at rest, mini-mental state examination (MMSE) scores, the incidence of nausea and vomiting, postoperative pain medications, and antiemetics were also recorded. Results: QoR-40 and MMSE scores of T0 showed no difference between two groups (QoR-40: 197.50 ± 2.57 vs. 195.83 ± 5.17), (MMSE: 26.83 ± 2.74 vs. 27.53 ± 2.88). Compared with the Con group, QoR-40 and MMSE scores of T1 and T2 were higher in the TEAS group (P < 0.05) (QoR-40: T1, 166.07 ± 8.44 vs. 175.33 ± 9.66; T2, 187.73 ± 5.47 vs. 191.40 ± 5.74), (MMSE: T1, 24.60 ± 2.35 vs. 26.10 ± 2.78; T2, 26.53 ± 2.94 vs. 27.83 ± 2.73). VAS scores of T1 and T2 were lower (P < 0.05) in the TEAS group (T1, 4.73 ± 1.53 vs. 3.70 ± 1.41; T2, 2.30 ± 0.95 vs. 1.83 ± 0.88); the incidence of postoperative nausea and vomiting (PONV), remedial antiemetics and remedial analgesia was lower in the TEAS group (P < 0.05) (PONV: 56.7% vs. 23.3%; incidence of remedial antiemetics: 53.3% vs. 23.3%; incidence of remedial analgesia: 80% vs. 43.3%). Conclusion The use of TEAS significantly promoted the quality of early recovery, improved MMSE scores and reduced the incidence of pain, nausea and vomiting in patients undergoing gynecological laparoscopic surgery. Trial registration ClinicalTrials.gov, NCT02619578. Registered on 2 December 2015. Trial registry name: https://clinicaltrials.gov


2020 ◽  
Vol 7 (3) ◽  
pp. 235-238
Author(s):  
Xue-Ping Zhu ◽  
Sha-Sha Zhao ◽  
Jie-Dan Qin

AbstractObjectiveTo evaluate the value of fast-track surgery (FTS) in gynecological laparoscopy during the perioperative period.MethodsThe clinical data of 234 patients who underwent gynecological laparoscopy from January to December in 2018 were collected. Of note, 117 patients received a routine nursing method (control group), and 117 patients received the FTS nursing method (observation group).ResultsCompared with the control group, FTS group had a quicker postoperative bowel function recovery, earlier to get out of bed, and a lower anxiety level (P < 0.05); The incidence of postoperative nausea and vomiting of two groups had no statistical difference.ConclusionsThe application of FTS in gynecological laparoscopy is safe, effective, and worth promoting.


2004 ◽  
Vol 100 (4) ◽  
pp. 811-817 ◽  
Author(s):  
Paul F. White ◽  
Hong Ma ◽  
Jun Tang ◽  
Ronald H. Wender ◽  
Alexander Sloninsky ◽  
...  

Background Analogous to the Bispectral Index (BIS) monitor, the auditory evoked potential monitor provides an electroencephalographic-derived index (AAI), which is alleged to correlate with the central nervous system depressant effects of anesthetic drugs. This clinical study was designed to test the hypothesis that intraoperative cerebral monitoring guided by either the BIS or the AAI value would facilitate recovery from general anesthesia compared with standard clinical monitoring practices alone in the ambulatory setting. Methods Sixty consenting outpatients undergoing gynecologic laparoscopic surgery were randomly assigned to one of three study groups: (1) control (standard practice), (2) BIS guided, or (3) AAI guided. Anesthesia was induced with 1.5-2.5 mg/kg propofol and 1-1.5 microg/kg fentanyl given intravenously. Desflurane, 3%, in combination with 60% nitrous oxide in oxygen was administered for maintenance of general anesthesia. In the control group, the inspired desflurane concentration was varied based on standard clinical signs. In the BIS- and AAI-guided groups, the inspired desflurane concentrations were titrated to maintain BIS and AAI values in targeted ranges of 50-60 and 15-25, respectively. BIS and AAI values, hemodynamic variables, and the end-tidal desflurane concentration were recorded at 5-min intervals during the maintenance period. The emergence times and recovery times to achieve specific clinical endpoints were recorded at 1- to 10-min intervals. The White fast-track and modified Aldrete recovery scores were assessed on arrival in the PACU, and the quality of recovery score was evaluated at the time of discharge home. Results A positive correlation was found between the AAI and BIS values during the maintenance period. The average BIS and AAI values (mean +/- SD) during the maintenance period were significantly lower in the control group (BIS, 41 +/- 10; AAI, 11 +/- 6) compared with the BIS-guided (BIS, 57 +/- 14; AAI, +/- 11) and AAI-guided (BIS, 55 +/- 12; AAI, 20 +/- 10) groups. The end-tidal desflurane concentration was significantly reduced in the BIS-guided (2.7 +/- 0.9%) and AAI-guided (2.6 +/- 0.9%) groups compared with the control group (3.6 +/- 1.5%). The awakening (eye-opening) and discharge times were significantly shorter in the BIS-guided (7 +/- 3 and 132 +/- 39 min, respectively) and AAI-guided (6 +/- 2 and 128 +/- 39 min, respectively) groups compared with the control group (9 +/- 4 and 195 +/- 57 min, respectively). More importantly, the median [range] quality of recovery scores was significantly higher in the BIS-guided (18 [17-18]) and AAI-guided (18 [17-18]) groups when compared with the control group (16 [10-18]). Conclusion Compared with standard anesthesia monitoring practice, adjunctive use of auditory evoked potential and BIS monitoring can improve titration of desflurane during general anesthesia, leading to an improved recovery profile after ambulatory surgery.


2020 ◽  
Vol 2020 ◽  
pp. 1-7 ◽  
Author(s):  
Sahar Hamzeh ◽  
Roya Safari-Faramani ◽  
Alireza Khatony

One of the problems of cancer patients is sleep disorder. Given the absence of studies on comparing the effect of inhalation aromatherapy with lavender and peppermint on the sleep quality of the cancer patients, this study was performed to compare the effect of inhalation aromatherapy with lavender and peppermint essential oils on the sleep quality of cancer patients. For this purpose, 120 patients were randomly allocated to three groups of lavender, peppermint, and control. The intervention groups received three drops of the essential oil for 7 days. In the control group, aromatic distilled water was used instead. Pittsburgh Sleep Quality Inventory (PSQI) was used. Before the intervention, no significant difference was observed between the mean PSQI scores of three groups, while the difference was statistically significant after the intervention. The mean PSQI scores were lower in lavender and peppermint groups than in the control group. Aromatherapy can improve the sleep quality of cancer patients. To confirm the findings, more studies should be done.


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