scholarly journals Effect of Hydrogen Gas Inhalation on Patient QOL After Hepatectomy: Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
Masaki Kaibori ◽  
Hisashi Kosaka
Keyword(s):  
Clinical Trial ◽  
Medical Care ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Ischemia Reperfusion ◽  
Hydrogen Gas ◽  
Inhalation Therapy ◽  
Randomized Controlled ◽  
Gas Inhalation ◽  
Hydrogen Gas Inhalation

Abstract Introduction: Molecular hydrogen had been considered inactive in vivo but is an antioxidant that selectively reduces highly toxic reactive oxygen species (ROS). Animal studies have reported that hydrogen gas inhalation helped alleviate cerebral and cardiac ischemia-reperfusion injuries. In humans, hydrogen inhalation therapy is presently approved as a treatment under Advanced Medical Care B in Japan (jRCTs031180352: limited to adult patients who suffered out-of-hospital cardiac arrest and are in a continuous coma) and its effectiveness is being examined in a clinical trial. The Japanese government has introduced the “Advanced Medical Care System” to promote the development of drugs and devices under governmental regulations. Advanced Medical Care B is a system designed for unapproved or off-label drugs or medical technologies used in a clinical trial setting. Hepatectomy is generally performed with repeated hepatic blood-flow occlusion and then reperfusion (ischemia and reperfusion). No report, however, has been made on ROS inhibition by hydrogen inhalation therapy or its effectiveness in post-hepatectomy patients. Hydrogen gas inhalation in the early stages after hepatectomy is anticipated to inhibit liver dysfunction by inhibiting ROS.Methods and analysis: This study is a randomized, controlled, double-blind trial which will be conducted as a “specified clinical trial” in accordance with the Clinical Trials Act in Japan. The subjects will be patients who will undergo hepatectomy and will be allocated randomly into group A with hydrogen gas inhalation or group B with air inhalation after hepatectomy. The study will examine if hydrogen gas inhalation improves QOL of post-hepatectomy patients. The primary endpoint is patient QOL (score of a 40-item quality of recovery questionnaire, QoR40) on postoperative day 3 and the secondary endpoints are QoR40s besides that on postoperative day 3, grade of postoperative complications (Clavien-Dindo score), level of pain (NRS: Numerical Rating Scale), amount of dietary intake, liver function, inflammation level, 8-hydroxydeoxyguanosine (urinary 8-OHdG) level, and number of pedometer-assessed steps.Ethics and dissemination: The protocol has been approved by the Niigata University Central Review Board of Clinical Research. The findings of this study will be disseminated widely through peer-reviewed publications and conference presentations.Trial registration number: jRCTs No. 03220332. Approved on 21 January 2021.

scholarly journals Effect of hydrogen gas inhalation on patient QOL after hepatectomy: protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Masaki Kaibori ◽  
Hisashi Kosaka
Keyword(s):  
Clinical Trial ◽  
Medical Care ◽  
Rating Scale ◽  
Ischemia Reperfusion ◽  
Hydrogen Gas ◽  
Trial Registration ◽  
Inhalation Therapy ◽  
Randomized Controlled ◽  
Gas Inhalation ◽  
Hydrogen Gas Inhalation

Abstract Introduction Molecular hydrogen had been considered inactive in vivo but is an antioxidant that selectively reduces highly toxic reactive oxygen species (ROS). Animal studies have reported that hydrogen gas inhalation helped alleviate cerebral and cardiac ischemia-reperfusion injuries. In humans, hydrogen inhalation therapy is presently approved as a treatment under Advanced Medical Care B in Japan (jRCTs031180352: limited to adult patients who suffered out-of-hospital cardiac arrest and are in a continuous coma) and its effectiveness is being examined in a clinical trial. The Japanese government has introduced the “Advanced Medical Care System” to promote the development of drugs and devices under governmental regulations. Advanced Medical Care B is a system designed for unapproved or off-label drugs or medical technologies used in a clinical trial setting. Hepatectomy is generally performed with repeated hepatic blood-flow occlusion and then reperfusion (ischemia and reperfusion). No report, however, has been made on ROS inhibition by hydrogen inhalation therapy or its effectiveness in post-hepatectomy patients. Hydrogen gas inhalation in the early stages after hepatectomy is anticipated to inhibit liver dysfunction by inhibiting ROS. Methods and analysis This study is a randomized, controlled, double-blind superiority trial, which will be conducted as a “specified clinical trial” in accordance with the Clinical Trials Act in Japan. Trial registration was prospectively completed before the first participant was enrolled. The subjects will be patients who will undergo hepatectomy and will be allocated randomly into group A with hydrogen gas inhalation or group B with air inhalation after hepatectomy. The study will examine if hydrogen gas inhalation improves QOL of post-hepatectomy patients. The primary endpoint is patient QOL (score of a 40-item quality of recovery questionnaire, QoR40) on postoperative day 3 and the secondary endpoints are QoR40s besides that on postoperative day 3, grade of postoperative complications (Clavien-Dindo score), level of pain (Numerical Rating Scale (NRS)), amount of dietary intake, liver function, inflammation level, 8-hydroxydeoxyguanosine (urinary 8-OHdG) level, and number of pedometer-assessed steps. Ethics and dissemination The study protocol has been approved by the Niigata University Central Review Board of Clinical Research. The findings of this study will be widely disseminated through peer-reviewed publications and conference presentations. Trial registration jRCTs 03220332. Registered on 21 January 2021

Hydrogen Gas Inhalation Alleviates Radiation-Induced Bone Marrow Damage in Cancer Patients

2019 ◽  
Author(s):  
Shin-ichi Hirano ◽  
Yukimasa Aoki ◽  
Ryosuke Kurokawa ◽  
Xiao-Kang Li ◽  
Naotsugu Ichimaru ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Cancer Patients ◽  
Hydrogen Gas ◽  
Bone Marrow Damage ◽  
Radiation Induced ◽  
Gas Inhalation ◽  
Hydrogen Gas Inhalation

scholarly journals Analgesic Effects of Preincision Ketamine on Postspinal Caesarean Delivery in Uganda’s Tertiary Hospital: A Randomized Clinical Trial

2017 ◽  
Vol 2017 ◽  
pp. 1-6
Author(s):  
Richard Mwase ◽  
Tonny Stone Luggya ◽  
John Mark Kasumba ◽  
Humphrey Wanzira ◽  
Andrew Kintu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Rating Scale ◽  
Breakthrough Pain ◽  
Numerical Rating Scale ◽  
Postoperative Pain Management ◽  
Mulago Hospital ◽  
Clinical Trial Registry ◽  
Analgesic Effects ◽  
Pain Scores ◽  
Intravenous Ketamine

Background. Good postoperative analgesic management improves maternal satisfaction and care of the neonate. Postoperative pain management is a challenge in Mulago Hospital, yet ketamine is accessible and has proven benefit. We determined ketamine’s postoperative analgesic effects.Materials and Methods. We did an RCT among consenting parturients that were randomized to receive either intravenous ketamine (0.25 mg/kg) or placebo after spinal anesthetic. Pain was assessed every 30 mins up to 24 hours postoperatively using the numerical rating scale. The first complaint of pain requiring treatment was noted as “time to first breakthrough pain.”Results. We screened 100 patients and recruited 88 that were randomized into two arms of 44 patients that received either ketamine or placebo. Ketamine group had 30-minute longer time to first breakthrough pain and lower 24-hour pain scores. Postoperative diclofenac consumption was lesser in the ketamine group compared to placebo and Kaplan-Meier graphs showed a higher probability of experiencing breakthrough pain earlier in the placebo group.Conclusion. Preincision intravenous ketamine (0.25 mg/kg) offered 30-minute prolongation to postoperative analgesia requirement with reduced 24-hour pain scores. We recommend larger studies to explore this benefit. This trial is registered with Pan African Clinical Trial Registry numberPACTR201404000807178.

scholarly journals Open release versus radiofrequency microtenotomy in the treatment of lateral epicondylitis: a prospective randomized controlled trial

2017 ◽  
Vol 10 (1) ◽  
pp. 45-51 ◽  
Author(s):  
Katharine Hamlin ◽  
Christopher Munro ◽  
Scott L. Barker ◽  
Sean McKenna ◽  
Kapil Kumar
Keyword(s):  
Randomized Controlled Trial ◽  
Grip Strength ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Lateral Epicondylitis ◽  
Open Release ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
Significant Difference

Background Optimal surgical treatment of lateral epicondylitis remains uncertain. Recently, radiofrequency microtenotomy (RFMT) has been proposed as a suitable treatment. We compared RFMT with standard open release (OR) in this prospective randomized controlled trial. Methods In total, 41 patients with symptoms for at least 6 months were randomized into two groups: 23 patients had RFMT and 18 had OR. Two patients from RFMT withdrew. Each patient underwent Numerical Rating Scale (NRS) pain score, grip strength and Disabilities of the Arm, Shoulder and Hand (DASH) scores pre-operatively and at 6 weeks. Pain and DASH scores were repeated at 6 months and 12 months. Results NRS pain scores improved by 4.8 points for RFMT and by 3.9 points for OR. There was a significant improvement in both groups from pre-operative scores, although there was no statistically significant difference between the groups at 1 year. Grip strength improved by 31% in the RFMT group compared to 38% in OR. There was no significant difference between the initial and 6 weeks scores or between treatments. At 1 year, DASH was 39.8 points for RFMT and 24.4 points for OR. There was a significant improvement in both groups from pre-operative scores, although there was no statistically significant difference between the groups at 1 year. Conclusions Both groups showed significant improvements and similar benefit to the patient. The results of the present study do not show any benefit of RFMT over the standard OR. As a result of the extra expense of RFMT, we therefore recommend that OR is offered as the standard surgical management.

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