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Completed

NCT Number: NCT00815022

Influence of Anesthetic Temperature on Cephalad Sensory Blockade With Spinal Anesthesia

Several factors influence the extension of anesthetic mixture during spinal anesthesia including anesthetic gravity, body position, drug volume, and drug-delivering velocity. However, the effect of temperature of anesthetic mixture on the cephalad sensory blockade is hitherto unknown. The investigators hypothesized that different temperatures of the anesthetic mixture had different velocity of extension after spinal anesthesia. In addition, previous studies suggest that parturients have relative higher sensitivity to temperature. Herein the investigators proposed that the temperature of anesthetic mixture had more extensive effect on the cephalad sensory blockade with spinal anesthesia for cesarean delivery.

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Key information

Conditions

Cesarean Delivery

Age range

19 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Nulliparous women
  • > 18 years and < 45 years

Exclusion criteria

  • Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
  • Participants younger than 18 years or older than 45 years
  • Those who were not willing to or could not finish the whole study at any time
  • Alcohol addictive or narcotic dependent patients
  • Subjects with a nonvertex presentation
  • Diagnosed diabetes mellitus and pregnancy-induced hypertension
  • Twin gestation and breech presentation
  • Pregnant fever

Treatment and study plan

bupivacaine/fentanyl/morphine

Drug

Hyperbaric bupivacaine 12 mg, fentanyl 10 microg and morphine 200 microg

Primary outcomes

  1. Maximum cephalad sensory blockade to pinprick, cold and touch

    Time frame: From the delivery of anesthetic mixture to 15 min immediate after spinal anesthesia

Secondary outcomes

  1. Velocity of the sensory blockade at identical body position

    Time frame: From the delivery of anesthetic mixture to 15 min immediate after spinal anesthesia

  2. The total dose of phenylephrine required to maintain baseline arterial blood pressure

    Time frame: From the delivery of anesthetic mixture to 25 min after spinal anesthesia

  3. Time interval of the occurrence of the hypotension

    Time frame: From the delivery of the anesthetic mixture to 25 min after spinal anesthesia

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Registry information

Official study title

Influence of Anesthetic Temperature on Cephalad Sensory Blockade With Spinal Anesthesia for Cesarean Delivery

Acronym: ATOCEB

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Dec 29, 2008
Registry last updated
Jan 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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