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Respiratory Depression clinical trials

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NCT ID: NCT05391555 Recruiting - Clinical trials for Respiratory Depression

Pupillary Unrest as an Indicator of Central Opioid Effect in Subjects 40-60 Years of Age

Start date: October 1, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This study will establish the relationship between magnitude of opioid exposure and a pupillary measure referred to as PUAL (pupillary unrest in ambient light), in subjects aged 40-60. Previous investigation demonstrated that loss of PUAL was a sensitive, discriminative indicator of opioid toxicity and respiratory depression among subjects aged 20-40 years old. Population data indicate that pupil size and PUAL decline slightly with age. The investigators will explore whether PUAL proves to be a sensitive indicator of opioid exposure and respiratory depression in this older group.

NCT ID: NCT05235503 Recruiting - Opioid Use Clinical Trials

Influence of Δ9-tetrahydrocannabinol (THC) on Oxycodone Induced Ventilatory Depression in Healthy Volunteers

COXY
Start date: December 9, 2021
Phase: Phase 4
Study type: Interventional

Rationale: Opioid misuse and abuse are common problems in the Western world. The rate of unintentional drug overdose is rapidly increasing, not only in the Unites States but also in the Netherlands. Additionally, it is well known that opioids are often used (and abused) in combination with other legal or illicit substances, for example cannabis, including medicinal (i.e. doctor prescribed) cannabis. A major opioid-induced adverse effect is respiratory depression and there are no data that show how oxycodone interacts with cannabis on the ventilatory control system. An appreciable effect is possible given the sedative effects of cannabis. Moreover, investigators previously showed that combining even a low dose of oxycodone (20 mg) with ethanol increased the likelihood of an apneic event (van der Schrier et al. Anesthesiology 2017; 102: 115-122). Because of this side effect and also due to the rising number of addicted chronic opioid users, there is an increasing imminent societal, political and medical interest in advancing research on opioids, opioid-drug interaction and alternatives for the treatment of various chronic illnesses and chronic pain. Hypothesis: The investigators hypothesize that cannabis will amplify the ventilatory depressant effect of oxycodone (primary end-point). Objective: The objective of the study is to quantify the interactive effect of Δ9-tetrahydrocannabinol (THC) and oxycodone on ventilatory control. Study design: Double blind, randomized cross-over, placebo-controlled design. Study population: Healthy human volunteers between the age of 18 and 45 years old. Intervention: Visit A: placebo capsule at t = 0 min + Bedrocan (22.4 mg THC) at t = 90 and 270 min; Visit B: oxycodone 20 mg at t = 0 min + Bedrocan (22.4 mg THC) at t = 90 and 270 min. Main study parameters/endpoints: Primary endpoint: The effect of inhaled THC on ventilation at an end-tidal PCO2 = 55 mmHg without and with concomitant intake of 20 mg oxycodone immediate release (IR) capsule in healthy volunteers 120 min after oxycodone intake. Secondary endpoints: (1) Outcome of Bowdle and Bond & Lader questionnaires; (2) Level of sedation; (3) Pain Pressure Threshold; (4) slope of the hypercapnic ventilatory response; (5) plasma concentrations of THC, 11-OH-THC and oxycodone; a secondary analysis will be performed on the pharmacokinetic and pharmacodynamic data (PKPD modeling).

NCT ID: NCT04046068 Recruiting - Post-operative Pain Clinical Trials

Multimodal Perioperative Pain Management: ComfortSafe Program

Start date: May 11, 2020
Phase:
Study type: Observational

Proposed is a demonstration project to characterize the immediate, short-term and long-term pain and other post-operative outcomes of 60, self-selected breast (n=20), caesarian-section (n=20) and abdominal (n=20) surgical patients who receive opioid-sparing, multimodal anesthesia and pain management care as guided by the ComfortSafe Pyramid.

NCT ID: NCT03775122 Recruiting - Clinical trials for Respiratory Depression

TAES Improve the Function of Respiration and Circulation on Elderly Patients Undergoing Colonoscopy Procedure

Start date: February 15, 2019
Phase: N/A
Study type: Interventional

To explore the effectiveness of transcutaneous acupuncture electrical stimulation (TAES), a non-invasive modality in improvement of the function of respiration and circulation on elder patient during colonoscopy.

NCT ID: NCT02819661 Recruiting - Clinical trials for Respiratory Depression

Respiratory Depression in Women With BMI≥30 Underwent Spinal Anesthesia With Intrathecal Morphine in Elective C-section

Start date: May 1, 2018
Phase: N/A
Study type: Interventional

The study will examine whether there is a difference in the frequencies of respiratory depression among obese women receiving spinal anesthesia combined with opioids compared to women with normal BMI. If such a risk exists further investigation will be required to establish the proper criteria for the administration of morphine with spinal anesthesia to obese women.

NCT ID: NCT01517217 Recruiting - Pain, Postoperative Clinical Trials

Effect of Postoperative Girdle Following Abdominal Surgery on Pulmonary Function, Mobilisation and Postoperative Pain

Start date: April 2011
Phase: N/A
Study type: Interventional

There is a considerable lack of knowledge in everyday surgical practice concerning treatment with a corset after laparotomy, in surgery for incisional hernia or as conservative treatment. The aims are to elucidate effects of corset treatment on patient experience and pain, physiology and abdominal wall strength. Effects of corset treatment after laparotomy will be studied in a randomised trial with the hypothesis that postoperative corset-use improves respiratory physiology and reduce pain. The primary end-point is PeakCoughFlow change, secondary end-points are vital capacity, residual volumes and patient perception as measured by the ventral hernia pain questionnaire (VHPQ) developed by our group. This study is powered for 50 patients. Conclusions from the study are of such a nature that they can be immediately transferred to clinical practice.

NCT ID: NCT01482078 Recruiting - Premature Birth Clinical Trials

Magnesium for Neonatal Neuroprotection and Mothers

MnMs
Start date: January 26, 2012
Phase:
Study type: Observational

Magnesium is a treatment for mothers to protect brains of babies born early. This study investigates combined effects of magnesium and spinal or epidural anesthesia on mothers having cesareans. The investigators will use a scoring system to measure sedation and devices that subjects breath in and out of to measure breathing strength. The investigators hypothesize the combination of magnesium and anesthesia will reduce breathing strength and cause sedation. This is an observational study comparing those having magnesium and anesthesia with those just having anesthesia. Routine medical care will not be altered. Results will hopefully allow anesthesiologists to provide better patient care.