scholarly journals Quality of Recovery after Laparoscopic Cholecystectomy Following Neuromuscular Blockade Reversal with Neostigmine or Sugammadex: A Prospective, Randomized, Controlled Trial

2021 ◽  
Vol 10 (5) ◽  
pp. 938
Author(s):  
Jiwon Han ◽  
Ah-Young Oh ◽  
Yong-Tae Jeon ◽  
Bon-Wook Koo ◽  
Bo Young Kim ◽  
...  
Keyword(s):  
Laparoscopic Cholecystectomy ◽  
Urinary Retention ◽  
Neuromuscular Blockade ◽  
Controlled Trial ◽  
Tracheal Extubation ◽  
Anesthetic Care ◽  
Quality Of Recovery ◽  
Patient Reported ◽  
Secondary Outcomes

The risk of neuromuscular blockade is certainly minimized by sugammadex in combination with monitoring. However, the effect of sugammadex-aided recovery on patients’ satisfaction is unclear. This study compared the Quality of Recovery (QoR)-15 score, which is a patient-reported outcome, in patients undergoing laparoscopic cholecystectomy. Eighty patients were randomly assigned to the neostigmine or sugammadex groups. At the end of surgery, neostigmine or sugammadex was administered, and tracheal extubation was performed after confirmation of a train of four ratio ≥ 0.9. The QoR-15 questionnaire was administered at 1 day before surgery and on post-operative days (POD) 1 and 2. The primary outcome was the QoR-15 score on POD 1. The secondary outcomes were the QoR-15 score on POD 2, modified Aldrete score, length of post-anesthetic care unit stay, post-operative pain, administration of anti-emetics, urinary retention, and length of hospital stay. No significant differences were found in QoR-15 scores on POD 1 (94.4 vs. 95.5, p = 0.87) or 2 (116.3 vs. 122, p = 0.33). Secondary outcomes were also comparable, with the exception of urinary retention (15.8% neostigmine vs. 2.6% sugammadex, p = 0.04). This study demonstrated that the quality of recovery was comparable between the neostigmine and sugammadex groups when reversal and tracheal extubation were performed in accordance with the current guidelines.

scholarly journals Normothermic Insufflation to Prevent Perioperative Hypothermia and Improve Quality of Recovery in Elective Colectomy Patients: Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Edyta Ryczek ◽  
Judith White ◽  
Ruth Louise Poole ◽  
Nicola Laura Reeves ◽  
Jared Torkington ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Small Scale ◽  
Perioperative Hypothermia ◽  
Quality Of Recovery ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Patient Reported

BACKGROUND Perioperative hypothermia during laparoscopy for bowel resection is a risk factor for postoperative medical complications and surgical wound infections. Despite various warming methods used during surgery, a significant number of patients experience perioperative hypothermia. Use of dry, unwarmed insufflation carbon dioxide (CO<sub>2</sub>) during laparoscopic procedures may contribute to this problem. Evidence exists that the HumiGard device, which humidifies and heats CO<sub>2</sub> for insufflation, can reduce the risk of perioperative hypothermia. OBJECTIVE The aim is to determine if insufflation with warmed, humidified CO<sub>2</sub> using the HumiGard device, alongside standard perioperative warming techniques, can improve patient recovery, including pain, surgical site infections, complications, and the use of analgesia compared with standard care alone. METHODS The study is a multicenter, randomized, blinded (patient, surgeon, and assessor), sham device-controlled, parallel group-controlled trial of 232 patients. The study aims to recruit patients undergoing elective laparoscopic, segmental, or total colectomy. Patients will be randomized to receive HumiGard plus standard care or standard care alone (1:1 ratio). The primary outcome is patient-reported quality of recovery, measured by the validated QoR-40 (quality of recovery) questionnaire, from baseline to postoperative day 1. Secondary outcomes include postoperative pain, the incidence of hypothermia, and the rate of postoperative complications. RESULTS The information gathered during a small-scale service evaluation at a single hospital was used to inform this study protocol. Before applying for a grant for this full randomized controlled trial, the authors will conduct a feasibility study of 40 patients to ensure that the protocol is feasible and to inform our sample size calculation. CONCLUSIONS The randomized controlled trial is designed to provide high-quality evidence on the effectiveness of the HumiGard device in potentially reducing the risk of perioperative hypothermia in patients scheduled for laparoscopic colectomy. The results will be used to improve the maintenance of adequate patient body temperature during surgery.

Ketamine does not enhance the quality of recovery following laparoscopic cholecystectomy: a randomized controlled trial

2017 ◽  
Vol 61 (7) ◽  
pp. 740-748 ◽  
Author(s):  
E. T. Moro ◽  
I. M. P. S. S. Feitosa ◽  
R. G. de Oliveira ◽  
G. F. P. Saraiva ◽  
R. Rosalino ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Laparoscopic Cholecystectomy ◽  
Controlled Trial ◽  
Quality Of Recovery ◽  
Randomized Controlled

scholarly journals Normothermic Insufflation to Prevent Perioperative Hypothermia and Improve Quality of Recovery in Elective Colectomy Patients: Protocol for a Randomized Controlled Trial

10.2196/14533 ◽  
2019 ◽  
Vol 8 (12) ◽  
pp. e14533
Author(s):  
Edyta Ryczek ◽  
Judith White ◽  
Ruth Louise Poole ◽  
Nicola Laura Reeves ◽  
Jared Torkington ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Small Scale ◽  
Perioperative Hypothermia ◽  
Quality Of Recovery ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Patient Reported

Background Perioperative hypothermia during laparoscopy for bowel resection is a risk factor for postoperative medical complications and surgical wound infections. Despite various warming methods used during surgery, a significant number of patients experience perioperative hypothermia. Use of dry, unwarmed insufflation carbon dioxide (CO2) during laparoscopic procedures may contribute to this problem. Evidence exists that the HumiGard device, which humidifies and heats CO2 for insufflation, can reduce the risk of perioperative hypothermia. Objective The aim is to determine if insufflation with warmed, humidified CO2 using the HumiGard device, alongside standard perioperative warming techniques, can improve patient recovery, including pain, surgical site infections, complications, and the use of analgesia compared with standard care alone. Methods The study is a multicenter, randomized, blinded (patient, surgeon, and assessor), sham device-controlled, parallel group-controlled trial of 232 patients. The study aims to recruit patients undergoing elective laparoscopic, segmental, or total colectomy. Patients will be randomized to receive HumiGard plus standard care or standard care alone (1:1 ratio). The primary outcome is patient-reported quality of recovery, measured by the validated QoR-40 (quality of recovery) questionnaire, from baseline to postoperative day 1. Secondary outcomes include postoperative pain, the incidence of hypothermia, and the rate of postoperative complications. Results The information gathered during a small-scale service evaluation at a single hospital was used to inform this study protocol. Before applying for a grant for this full randomized controlled trial, the authors will conduct a feasibility study of 40 patients to ensure that the protocol is feasible and to inform our sample size calculation. Conclusions The randomized controlled trial is designed to provide high-quality evidence on the effectiveness of the HumiGard device in potentially reducing the risk of perioperative hypothermia in patients scheduled for laparoscopic colectomy. The results will be used to improve the maintenance of adequate patient body temperature during surgery. International Registered Report Identifier (IRRID) PRR1-10.2196/14533

scholarly journals The impact of multimodal analgesia based enhanced recovery protocol on quality of recovery after laparoscopic gynecological surgery: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zhiyu Geng ◽  
Hui Bi ◽  
Dai Zhang ◽  
Changji Xiao ◽  
Han Song ◽  
...  
Keyword(s):  
Enhanced Recovery ◽  
Controlled Trial ◽  
Bowel Function ◽  
Multimodal Analgesia ◽  
Study Group ◽  
Gynecological Surgery ◽  
Quality Of Recovery ◽  
Enhanced Recovery Protocol ◽  
The Impact

Abstract Background Our objective was to evaluate the impact of multimodal analgesia based enhanced recovery protocol on quality of recovery after laparoscopic gynecological surgery. Methods One hundred forty female patients scheduled for laparoscopic gynecological surgery were enrolled in this prospective, randomized controlled trial. Participants were randomized to receive either multimodal analgesia (Study group) or conventional opioid-based analgesia (Control group). The multimodal analgesic protocol consists of pre-operative acetaminophen and gabapentin, intra-operative flurbiprofen and ropivacaine, and post-operative acetaminophen and celecoxib. Both groups received an on-demand mode patient-controlled analgesia pump containing morphine for rescue analgesia. The primary outcome was Quality of Recovery-40 score at postoperative day (POD) 2. Secondary outcomes included numeric pain scores (NRS), opioid consumption, clinical recovery, C-reactive protein, and adverse events. Results One hundred thirty-eight patients completed the study. The global QoR-40 scores at POD 2 were not significantly different between groups, although scores in the pain dimension were higher in Study group (32.1 ± 3.0 vs. 31.0 ± 3.2, P = 0.033). In the Study group, NRS pain scores, morphine consumption, and rescue analgesics in PACU (5.8% vs. 27.5%; P = 0.0006) were lower, time to ambulation [5.0 (3.3–7.0) h vs. 6.5 (5.0–14.8) h; P = 0.003] and time to bowel function recovery [14.5 (9.5–19.5) h vs.17 (13–23.5) h; P = 0.008] were shorter, C-reactive protein values at POD 2 was lower [4(3–6) ng/ml vs. 5 (3–10.5) ng/ml; P = 0.022] and patient satisfaction was higher (9.8 ± 0.5 vs. 8.8 ± 1.2, P = 0.000). Conclusion For minimally invasive laparoscopic gynecological surgery, multimodal analgesia based enhanced recovery protocol offered better pain relief, lower opioid use, earlier ambulation, faster bowel function recovery and higher patient satisfaction, while no improvement in QoR-40 score was found. Trial registration ChiCTR1900026194; Date registered: Sep 26,2019.

scholarly journals Quality of life assessments in clinical practice using either the EORTC-QLQ-C30 or the SEIOQL-DW: a randomized study

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Åsa Kettis ◽  
Hanna Fagerlind ◽  
Jan-Erik Frödin ◽  
Bengt Glimelius ◽  
Lena Ring
Keyword(s):  
Quality Of Life ◽  
Clinical Practice ◽  
Significant Difference ◽  
Patient Reported ◽  
Health Related Qol ◽  
Health Related ◽  
Secondary Outcomes ◽  
The Impact ◽  
Over Time

Abstract Background Effective patient-physician communication can improve patient understanding, agreement on treatment and adherence. This may, in turn, impact on clinical outcomes and patient quality of life (QoL). One way to improve communication is by using patient-reported outcome measures (PROMs). Heretofore, studies of the impact of using PROMs in clinical practice have mostly evaluated the use of standardized PROMs. However, there is reason to believe that individualized instruments may be more appropriate for this purpose. The aim of this study is to compare the effectiveness of the standardized QoL-instrument, the European Organization for Research and Treatment of Cancer Quality of Life C-30 (EORTC-QOL-C30) and the individualized QoL instrument, the Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW), in clinical practice. Methods In a prospective, open-label, controlled intervention study at two hospital out-patient clinics, 390 patients with gastrointestinal cancer were randomly assigned either to complete the EORTC-QOL-C30 or the SEIQoL-DW immediately before the consultation, with their responses being shared with their physician. This was repeated in 3–5 consultations over a period of 4–6 months. The primary outcome measure was patients’ health-related QoL, as measured by FACIT-G. Patients’ satisfaction with the consultation and survival were secondary outcomes. Results There was no significant difference between the groups with regard to study outcomes. Neither intervention instrument resulted in any significant changes in health-related QoL, or in any of the secondary outcomes, over time. This may reflect either a genuine lack of effect or sub-optimization of the intervention. Since there was no comparison to standard care an effect in terms of lack of deterioration over time cannot be excluded. Conclusions Future studies should focus on the implementation process, including the training of physicians to use the instruments and their motivation for doing so. The effects of situational use of standardized or individualized instruments should also be explored. The effectiveness of the different approaches may depend on contextual factors including physician and patient preferences.

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

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jae Yen Song ◽  
Hoon Choi ◽  
Minsuk Chae ◽  
Jemin Ko ◽  
Young Eun Moon
Keyword(s):  
General Anesthesia ◽  
Assessment Tool ◽  
Controlled Trial ◽  
Perioperative Period ◽  
Postoperative Outcomes ◽  
Control Group ◽  
Quality Of Recovery ◽  
Gynecological Laparoscopy ◽  
Prospective Randomized Controlled Trial

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

scholarly journals Task-oriented exercises improve disability of working patients with surgically-treated proximal humeral fractures. A randomized controlled trial with one-year follow-up

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marco Monticone ◽  
Igor Portoghese ◽  
Daniele Cazzaniga ◽  
Valentina Liquori ◽  
Giuseppe Marongiu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Group Differences ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
One Year ◽  
Task Oriented

Abstract Background General physiotherapy is a common means of rehabilitation after surgery for proximal humeral fracture (PHF). Better-targeted exercises seem worthy of investigation and the aim of this study was to assess the efficacy of a rehabilitation program including task-oriented exercises in improving disability, pain, and quality of life in patients after a PHF. Methods By means of a randomized controlled trial with one-year follow-up, 70 working patients (mean age of 49 ± 11 years; 41 females), who were selected for open reduction and internal fixation with plates caused by PHF, were randomized to be included in an experimental (n = 35) or control group (n = 35). There was a permuted-block randomization plan, and a list of program codes was previously created; subsequently, an automatic assignment system was used to conceal the allocation. The first group underwent a supervised rehabilitation program of task-oriented exercises based on patients’ specific job activities, and occupational therapy. The second group underwent general physiotherapy, including supervised mobility, strengthening and stretching exercises. Both groups individually followed programs of 60-min session three times per week for 12 weeks in the outpatient setting. The Disability Arm Shoulder Hand questionnaire (DASH; scores range from 0 to 100; primary outcome), a Pain intensity Numerical Rating Scale (scores range 0 to 10; secondary outcomes), and the Short-Form Health Survey (scores range from 0 to 100; secondary outcomes) assessed the interventions. Participants were evaluated before surgery, before and after rehabilitation (primary endpoint), and at the one-year follow-up (secondary endpoint). A linear mixed model analysis for repeated measures was carried out for each outcome measure (p < 0.05). Results Time, group and time by group showed significant effects for all outcome measures in favour of the experimental group. The DASH and the DASH work achieved clinically important between-group differences of 16.0 points (95% confidence interval [C.I.] 7.3 to 24.7) and 19.7 (95% C.I. 9.0 to 30.5) at follow-up, respectively. The NRS achieved a between-group difference of 2.9 (95% C.I. 1.0 to 3.9) at follow-up. As for SF-36, there were between-group differences ranging from 17.9 to 37.0 at follow-up. Conclusions A rehabilitation program based on task-oriented exercises was useful in improving disability, pain, and quality of life in working patients after PHFs. Improvements lasted for at least 12 months. Trial registration On 16/12/2019, the trial was retrospectively registered in the ISRCTN registry with the ID number 17996552.

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