scholarly journals Self-produced audio-visual animation introduction alleviates preoperative anxiety in pediatric strabismus surgery: a randomized controlled study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yuexi Jin ◽  
Aifen Jiang ◽  
Wanna Jiang ◽  
Wenxin Wu ◽  
Lisha Ye ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Study ◽  
Strabismus Surgery ◽  
Preoperative Anxiety ◽  
Controlled Study ◽  
Average Score ◽  
Anesthesia Induction ◽  
Emergence Agitation ◽  
Clinical Trial Registry ◽  
Group A

Abstract Background Hospital anxiety caused by strabismus surgery has an unpleasant and disturbing feeling for both children and their parents. This study aimed to determine the effect of viewing a self-produced audio-visual animation introduction on preoperative anxiety and emergence agitation of pediatric patients undergoing strabismus surgery. Methods In this prospective randomized study, 1 hundred children scheduled for strabismus surgery with aged 3 ~ 6 years. The children were randomly divided into 2 groups (n = 50 for each), Group A: using a self-produced audio-visual animation introduction; Group C: controlled group without audio-visual animation introduction. Children’s preoperative anxiety was determined by the modified Yale Preoperative Anxiety Scale (mYPAS) at different time points: the night before surgery(T1), at pre-anesthetic holding room(T2), and just before anesthesia induction(T3). The Spielberger State-Trait Anxiety Inventory (STAI) was used to record the anxiety of parents at T1,T2 and T3. The incidence and the degree of emergence agitation were recorded. Results The mYPAS scores at T2 and T3 were higher than T1(p < 0.05) in both groups. The average score of mYPAS in Group A was significantly lower than in Group C at T2 and T3(p < 0.05). The STAI scores in Group A at T2 and T3 were significantly lower than in Group C(p < 0.05). The incidence of agitation in Group A was lower than that in Group C(p < 0.05). Conclusions Based on the findings, viewing a self-produced audio-visual animation can effectively alleviate the preoperative anxiety for both children and their parents in pediatric strabismus surgery, and it was effective for reducing emergence agitation as well. Trial registration The trial was prospectively registered before patient enrollment at Chinese Clinical Trial Registry (Clinical Trial Number: ChiCTR1900025116, Date: 08/12/2019).

scholarly journals Magnesium Supplementation and Postoperative Recovery Quality in Children Undergoing Strabismus Surgery: A Prospective, Randomised, Controlled Study

2020 ◽  
Author(s):  
Ji-Hyun Lee ◽  
Seungeun Choi ◽  
Minkyoo Lee ◽  
Young-Eun Jang ◽  
Eun-Hee Kim ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Strabismus Surgery ◽  
Preoperative Anxiety ◽  
Controlled Study ◽  
Control Group ◽  
Anesthesia Induction ◽  
Emergence Agitation ◽  
Magnesium Supplementation ◽  
Respiratory Events ◽  
Postanesthetic Care Unit

Abstract Background: The benefits of intraoperative magnesium supplementation have been reported. In this prospective, randomized study, the effects of magnesium supplementation during general anesthesia on emergence agitation and postoperative pain in children were evaluated.Methods: A total of 66 children aged 2 to 5 years who underwent strabismus surgery were assigned to the magnesium or to the control group. Preoperative anxiety was assessed using the modified Yale Preoperative Anxiety Scale. After anesthesia induction, the magnesium group received an initial loading dose of 30 mg/kg magnesium sulphate over 10 min and, then, continuous infusion of 10 mg/kg per h until 10 min before the end of the surgery. The control group received an equal volume of normal saline via the same regimen. The Pediatric Anesthesia Emergence Delirium (PAED) score, pain score, and respiratory events were assessed at the postanesthetic care unit.Results: Data obtained from 65 children were analyzed. The PAED and pain scores of the two groups did not differ significantly. There were 26 of 33 (78.8%) and 27 of 32 (84.4%) children with emergence agitation in the control and the magnesium groups, respectively (odds ratio 0.69, 95% CI 0.19–2.44; p = 0.561). The preoperative anxiety score was not significantly correlated with the PAED score. The incidence of respiratory events during the emergence period did not differ significantly between the two groups. Conclusions: Magnesium supplementation during anesthesia had no significant effects on the incidence of emergence agitation or postoperative pain in children undergoing strabismus surgery.Clinical trial registry: ClinicalTrials.gov (NCT03132701)

scholarly journals Effect of magnesium supplementation on emergence delirium and postoperative pain in children undergoing strabismus surgery: a prospective randomised controlled study

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Ji-Hyun Lee ◽  
Seungeun Choi ◽  
Minkyoo Lee ◽  
Young-Eun Jang ◽  
Eun-Hee Kim ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Randomized Study ◽  
Strabismus Surgery ◽  
Preoperative Anxiety ◽  
Controlled Study ◽  
Control Group ◽  
Magnesium Supplementation ◽  
Emergence Period ◽  
Emergence Delirium ◽  
Respiratory Events

Abstract Background The benefits of intraoperative magnesium supplementation have been reported. In this prospective, randomized study, the effects of magnesium supplementation during general anaesthesia on emergence delirium and postoperative pain in children were evaluated. Methods A total of 66 children aged 2 to 5 years who underwent strabismus surgery were assigned to the magnesium or to the control group. Preoperative anxiety was assessed using the modified Yale Preoperative Anxiety Scale. After anaesthesia induction, the magnesium group received an initial loading dose of 30 mg/kg magnesium sulphate over 10 min and, then, continuous infusion of 10 mg/kg per h until 10 min before the end of the surgery. The control group received an equal volume of normal saline via the same regimen. The Paediatric Anaesthesia Emergence Delirium (PAED) score, pain score, and respiratory events were assessed at the postanaesthetic care unit. Results Data obtained from 65 children were analyzed. The PAED and pain scores of the two groups did not differ significantly. There were 26 of 33 (78.8%) and 27 of 32 (84.4%) children with emergence delirium in the control and the magnesium groups, respectively (odds ratio 0.69, 95% CI 0.19–2.44; p = 0.561). The preoperative anxiety score was not significantly correlated with the PAED score. The incidence of respiratory events during the emergence period did not differ significantly between the two groups. Conclusions Magnesium supplementation during anaesthesia had no significant effects on the incidence of emergence delirium or postoperative pain in children undergoing strabismus surgery. Trial registration ClinicalTrials.gov (NCT03132701). Prospectively registered May 8, 2017.

Does the Laminar Airflow System Affect the Development of Perioperative Hypothermia? A Randomized Clinical Trial

2021 ◽  
pp. 193758672098585
Author(s):  
Recai Dagli ◽  
Fatma Çelik ◽  
Hüseyin Özden ◽  
Serdar Şahin
Keyword(s):  
Clinical Trial ◽  
Laparoscopic Cholecystectomy ◽  
Tympanic Membrane ◽  
Randomized Study ◽  
Hvac Systems ◽  
Anesthesia Induction ◽  
Temperature Changes ◽  
Perioperative Hypothermia ◽  
Surgical Evaluation ◽  
Turbulent Airflow

Objectives: We aimed to compare tympanic membrane temperature changes and the incidence of inadvertent perioperative hypothermia (IPH) in patients undergoing laparoscopic cholecystectomy under general anesthesia in laminar airflow systems (LAS-OR) and conventional turbulent airflow systems (CAS-OR). Background: Different heating, ventilation, and air-conditioning (HVAC) systems are used in the operating room (OR), such as LAS and CAS. Laminar airflow is directed directly to the patient in LAS-OR. Does laminar airflow in ORs cause faster heat loss by convection? Methods: This is a prospective, randomized study. We divided 200 patients with simple randomization (1:1), as group LAS and group CAS, and took the patients into the LAS-OR or CAS-OR for the operation. Clinical trial number: IRCT20180324039145N3. The tympanic membrane temperatures of patients were measured (°C) before anesthesia induction ( T 0) and then every 15 min during surgery ( Tn). Changes (Δ n) between T 0 and Tn were measured. Results: In the first 30 min, there was a temperature decrease of approximately 0.8 °C (1.44 °F) in both groups. Temperature decreases at 45 min were higher in group LAS than in group CAS but not statistically significant, Δ45, respectively, 0.89 (95% confidence interval [CI] [0.77, 1.02]) versus 0.77 (95% CI [0.69, 0.84]; p = .09). IPH occurred in a total of 60.9% (112 of 184) of patients in the entire surgical evaluation period in group LAS and group CAS (58.9% vs. 62.8%, p = . 59). Conclusions: IPH is seen frequently in both HVAC systems. Clinically, the advantage of HVAC systems relative to each other has not been demonstrated during laparoscopic cholecystectomy.

scholarly journals Effect of dexmedetomidine on prevention of postoperative nausea and vomiting in pediatric strabismus surgery: A randomized controlled study

2020 ◽  
Author(s):  
shuangshuang li ◽  
Tingjie Liu ◽  
Junming Xia ◽  
Jie Jia ◽  
Wenxian Li
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Postoperative Nausea ◽  
Recovery Time ◽  
Pediatric Patients ◽  
Postoperative Nausea And Vomiting ◽  
Strabismus Surgery ◽  
Nausea And Vomiting ◽  
Emergence Agitation ◽  
Oculocardiac Reflex

Abstract Background: Postoperative nausea and vomiting (PONV) are common side-effects following strabismus surgery. The present study aimed to compare the effects of different doses of dexmedetomidine (DEX) on PONV incidence in pediatric patients undergoing strabismus surgery. Methods: In this prospective randomized double-blinded study, 126 pediatric patients undergoing strabismus surgery were randomized into one of three groups: Placebo group, normal saline; DEX1 group, 0.3 ug/kg dexmedetomidine, and DEX2 group, 0.5 ug/kg dexmedetomidine. Oculocardiac reflex (OCR) events were recorded during surgery. PONV or postoperative vomiting (POV) was recorded for 24 hours in the ward. Pediatric anesthesia emergence delirium (PAED) scale and emergence agitation (EA) scale were recorded in the recovery room. Results: Intraoperative OCR was significantly reduced in DEX2 group (42%) as compared to that of Placebo group (68%) (p=0.0146). During the first 24 hours post-op, the overall incidence of PONV was significantly lower in DEX2 group (10%) than that of Placebo group (32%) (p=0.0142). There was no significant difference in POV among the three groups. PAED or EA scores among the three groups were similar during recovery time. Conclusion: Dexmedetomidine (0.5 ug/kg) reduced OCR and PONV without lengthening extubation time or recovery time in pediatric patients undergoing strabismus surgery. Trial registration：The trial was prospectively registered before patient enrollment at Chinese Clinical Trial Registry (Clinical Trial Number: ChiCTR1800020176, Date: 12/19/2018). Keywords: Dexmedetomidine, Postoperative nausea and vomiting, Strabismus surgery, Oculocardiac reflex, Emergence agitation

scholarly journals Preoperative Anxiety and Postoperative Pain in Patients With Laparoscopic Hysterectomy

2021 ◽  
Vol 12 ◽  
Author(s):  
Lin Zhang ◽  
Li-Jun Hao ◽  
Xiao-Lai Hou ◽  
Ya-Ling Wu ◽  
Lu-Shi Jing ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Postoperative Analgesia ◽  
Rating Scale ◽  
Laparoscopic Hysterectomy ◽  
Preoperative Anxiety ◽  
Chinese Patients ◽  
Average Score ◽  
Significant Difference ◽  
Group A ◽  
Group B

Objective: This study was designed to investigate preoperative anxiety situations and postoperative pain degree in Chinese patients undergoing laparoscopic hysterectomy and to analyze the related factors of preoperative anxiety and the correlation between preoperative anxiety and postoperative pain to provide a reference for effective postoperative analgesia management.Methods: A total of 100 female patients undergoing laparoscopic hysterectomy were enrolled in this study and randomly divided into two groups (n = 50, each). In group A, the patients were treated with dexmedetomidine and sufentanil for postoperative analgesia. In group B, the patients were treated with sufentanil alone for postoperative analgesia. All patients were evaluated with a self-rating anxiety scale (SAS) 1 day before the operation. The patients’ pain was evaluated using the numerical rating scale (NRS) 1 day after the operation, and data were recorded.Results: In these 100 patients, the highest preoperative SAS score was 48, and the average score was 40.99 ± 4.55 points, which is higher than the norm in China. There were significant differences in preoperative SAS scores among patients with different occupations and previous surgical experience (P &lt; 0.05). There was no significant difference in SAS scores among patients with different education levels (P &gt; 0.05). The postoperative NRS score of group A was significantly higher than that of group B, and the difference was statistically significant (P &lt; 0.05). The correlation coefficients between SAS scores and NRS scores in groups A and B were 0.836 and 0.870, respectively, presenting with a significantly positive correlation.Conclusion: Preoperative anxiety is an important predictor of postoperative pain. Patients undergoing laparoscopic hysterectomy have preoperative anxiety. The degree of anxiety is influenced by the occupation and previous operation experience of the patients, and patients with higher preoperative anxiety have greater postoperative pain. In addition, we should not neglect the management of postoperative pain because of the small trauma of laparoscopic surgery, and dexmedetomidine combined with sufentanil can improve the postoperative analgesic effect.

scholarly journals Comparative study between intrathecal dexmedetomidine and intrathecal magnesium sulfate for the prevention of post-spinal anaesthesia shivering in uroscopic surgery; (RCT)

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Heba Omar ◽  
Wessam Adel Aboella ◽  
Mohammed Mahmoud Hassan ◽  
Amany Hassan ◽  
Passaint Hassan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Magnesium Sulfate ◽  
Spinal Anaesthesia ◽  
Sedation Score ◽  
Trial Registration ◽  
Controlled Study ◽  
Clinical Trial Registry ◽  
Hyperbaric Bupivacaine ◽  
Clinical Trial Registration ◽  
Group D

Abstract Background Hypothermia and shivering are common complications after spinal anaesthesia, especially after uroscopic procedures in which large amounts of cold intraluminal irrigation fluids are used. Magnesium sulfate and dexmedetomidine are the most effective adjuvants with the least side effects. The aim of this study was to compare the effects of intrathecal dexmedetomidine versus intrathecal magnesium sulfate on the prevention of post-spinal anaesthesia shivering. Methods This prospective randomized, double-blinded controlled study included 105 patients who were scheduled for uroscopic surgery at the Kasr El-Aini Hospital. The patients were randomly allocated into three groups. Group C (n = 35) received 2.5 ml of hyperbaric bupivacaine 0.5% (12.5 mg) + 0.5 ml of normal saline, Group M (n = 35) received 2.5 ml of hyperbaric bupivacaine 0.5% (12.5 mg) + 25 mg of magnesium sulfate in 0.5 ml saline, and Group D (n = 35) received 2.5 ml of hyperbaric bupivacaine 0.5% (12.5 mg) + 5 μg of dexmedetomidine in 0.5 ml saline. The primary outcomes were the incidence and intensity of shivering. The secondary outcomes were the incidence of hypothermia, sedation, the use of meperidine to control shivering and complications. Results Group C had significantly higher proportions of patients who developed shivering (21), developed grade IV shivering (20) and required meperidine (21) to treat shivering than group M (8,5,5) and group D (5,3,6), which were comparable to each other. The time between block administration and meperidine administration was similar among the three groups. Hypothermia did not occur in any of the patients. The three groups were comparable regarding the occurrence of nausea, vomiting, bradycardia and hypotension. All the patients in group C, 32 patients in group M and 33 patients in group D had a sedation score of 2. Three patients in group M and 2 patients in group D had a sedation score of 3. Conclusions Intrathecal injections of both dexmedetomidine and magnesium sulfate were effective in reducing the incidence of post-spinal anaesthesia shivering. Therefore, we encourage the use of magnesium sulfate, as it is more physiologically available, more readily available in most operating theatres and much less expensive than dexmedetomidine. Trial registration Clinical trial registration ID: Pan African Clinical Trial Registry (PACTR) Trial Number PACTR201801003001727; January 2018, “retrospectively registered”.

INNOVA: Interval or neoadjuvant chemotherapy in rectal cancer—A phase II randomized study comparing interval versus neoadjuvant chemotherapy in magnetic resonance imaging-defined high-risk rectal cancer.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 91-91
Author(s):  
Ramakrishnan Ayloor Seshadri ◽  
Trivadi S. Ganesan ◽  
Manikandan Dhanushkodi ◽  
Arunkumar M N ◽  
Shirley Sundersingh
Keyword(s):  
Clinical Trial ◽  
Rectal Cancer ◽  
High Risk ◽  
Neoadjuvant Chemotherapy ◽  
Randomized Study ◽  
Neoadjuvant Treatment ◽  
Complete Response ◽  
Phase Iii ◽  
Clinical Trial Registry ◽  
Grade 3

91 Background: Total neoadjuvant treatment is a promising option in rectal cancer. We aim to compare neoadjuvant versus interval chemotherapy in high risk rectal cancer to identify the optimal sequencing of treatment. Methods: Using a Simon two-stage design, newly diagnosed MRI defined high risk rectal cancer patients were randomly assigned in a 1:1 ratio to receive three 21 day cycles of chemotherapy with Capecitabine 1000 mg/m2 and Oxaliplatin 130 mg/m2 either before (Arm A-neoadjuvant) or after (Arm B-interval) chemoradiation followed by surgery. Primary end point was the pathological complete response (pCR) following surgery. A heirarchial model was used to assess the primary and secondary end points (toxicity and compliance) and compare the two regimens. (Clinical Trial Registry of India No. CTRI/2015/01/005385). Results: In this single centre study conducted between November 2015 and February 2020, 42 patients were randomised in the first stage. A pCR was seen in 4 patients in Arm A and 6 in Arm B. Hence another 52 patients were randomised in the second stage of which an additional 3 and 2 patients had a pCR leading to an overall pCR of 7 and 8 patients (15.5% vs 17% and 18.4% vs 19.5% in the intent-to-treat and per-protocol populations in Arm A and B respectively. This exceeded the minimum predetermined number of 5 pCR needed to qualify for further evaluation for each arm. Grade ≥3 toxicity was observed in 2.2% of 132 cycles and 4.6% of 129 cycles of chemotherapy delivered in 45 and 43 patients in Arm A and B respectively while 11/43 (25.5%) and 10/47 (21.2%) patients experienced grade ≥3 toxicity during chemoradiation. Treatment break of > 7 days was seen in 23.2% and 29.7% of patients in Arm A and B respectively while 93.3% in Arm A and 100% of patients in Arm B completed all 3 planned cycles of pre-operative chemotherapy. A non-significant trend towards greater pathological downstaging was seen in Arm B than in Arm A (ypT1-2 39% vs 26.3%; p = 0.1 and ypN0 68.3% vs 57.9%; p = 0.5 respectively). Conclusions: In this phase two study, both neoadjuvant and interval chemotherapy emerged eligible for further evaluation against the standard of care in a future phase III study. Although we could not pick one winner based on pCR, toxicity or compliance, the greater downstaging observed with interval chemotherapy suggests it could play a greater role in an organ preservation approach. Clinical trial information:CTRI/2015/01/005385, UTN no: U111111650578.

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