NCT06889337Completed
A Comparative Study of Supine Position and the Head Elevated Position on the Level of Sensory Block After Spinal Anesthesia in Morbidly Obese Parturient Undergoing Elective Cesarean Delivery
Source: ClinicalTrials.gov · Last updated 21 Mar 2025
Brief summary (registry, in English)
The sniffing position defined as neck flexion with upper cervical extension, is traditionally recommended for general anesthesia induction, as it improves laryngoscopic views. However, the head elevation beyond the sniffing position, also known as ramped position or head elevated laryngoscopy position, usually achieved by specially designed pillows such as the Oxford head elevating laryngoscopy pillow (Alma Medical,Oxford, UK) or the Troop® elevation pillow (Mercury Medical, Clearwater, FL, USA)has been shown to not only increase respiratory reserve but also to improve laryngeal views in patients undergoing bariatric surgery. Additionally it helps in pre-oxygenating the patient more efficiently by keeping the airway patent and provides easier bag-mask ventilation. It may also benefit the term parturient in a similar way by improving functional residual capacity (FRC), ventilation and comfort. However, this positon may affect the cephalad spread of the intrathecal local anesthetic. Two earlier studies looked at the intrathecal local anesthetic spread in obstetric patients when placed in the head elevated laryngoscopy position, and both suggested poor cephalad spread, with patients requiring higher supplementation. However, both studies excluded morbidly obese patients. The Investigators hypothesized that in obese parturients with BMI more than or equal 40, higher intra-abdominal pressures and possibly lower CSF volumes will counteract the poor cephalad spread associated with this position. The aim of this study is to determine the effect of a ramped position on intrathecal local anesthetic spread in the morbidly obese term parturients with BMI more than or equal 40 undergoing elective Cesarean delivery(CD).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 90 (actual)
- First submitted
- 23 Feb 2025
- Start date
- 1 May 2023
- Primary completion date
- 11 Jul 2024
- Lead sponsor
- Hamad Medical Corporation
- Diseases
- Obesity
- NCT number
- NCT06889337
What you commit to
- Study type: Interventional
- Participants enrolled: 90
- From 1 May 2023 to the primary completion date, 11 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Women with comorbidities other than obesity, gestational diabetes or gestational hypothyroidism.
Age
- Age \<18 years
Other
- BMI less than 39.9 and \<37 weeks of gestation
- parturient preference for general anesthesia or contraindication to neuraxial anesthesia
- women in active labor (\>3 cm dilated with regular uterine contractions)
- emergency CD
- Possible uterine over-distension or under-distension (e.g. polyhydramnios, estimated fetal weight \>4 kg by ultrasound scan, or oligohydramnios or concern for fetal IUGR)
- maternal height \<150 cm or \>180 cm.
- Patients for which more than 2 minutes is taken in positioning after anesthesia induction (Time 0).
Who the study is looking for
- Age 18yrs of age or more
- BMI 40 or more and more than or equal 37 weeks of gestation
- elective CD
- consented for neuraxial anesthesia
- singleton fetus
- ASA class 3 (no co-morbidities except morbid obesity, gestational diabetes, and gestational hypothyroidism)
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hamad Medical Corporation Coordinator of this site? Confirm its status | Doha | Qatar | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.