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The early sedation effect of intrathecal morphine administration on adult patients undergoing urogenital surgeries

The early sedation effect of intrathecal morphine administration assessed by intraoperative Bispectral index monitoring and postoperative Ramsey Sedation Scale on adult patients undergoing urogenital surgeries

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001034224
Acronym
ITMT (Intrathecal morphine trail)
Enrollment
182
Registered
2018-06-20
Start date
2018-07-11
Completion date
2018-10-02
Last updated
2018-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Intrathecal administration of morphine is usually performed for both upper and lower abdominal surgeries due to better analgesia and longer duration of action. Although it is accepted as the “gold-standart” opioid for intrathecal administration, morphine has some potential adverse effects as well. The primary aim of this study is to assess early sedation effect of intrathecal morphine by bispectral index monitoring and respiratory depression by peripheral oxygen saturation of the patients undergoing lower abdominal surgeries the first hour after spinal anesthesia. Our secondary aim is to assess the sedation effect of intrathecal morhine by Ramsey sedation scale in the second hour.

Interventions

The patients who are between 18 and 65 years of age and referred to urogenital surgeries will be randomly divided into two groups. In the operating room, ECG, non invasive blood pressure, heart rate and Bispectral index monitoring will be applied to all of the patients. The patients will receive 0.03 mg/kg midazolam before spinal anesthesia. During spinal anesthesia, a single dose of 200 microgram intrathecal morphine (0.2 ml) and 13 mg intrathecal bupivacaine will be administered. While in the

The patients who are between 18 and 65 years of age and referred to urogenital surgeries will be randomly divided into two groups. In the operating room, ECG, non invasive blood pressure, heart rate and Bispectral index monitoring will be applied to all of the patients. The patients will receive 0.03 mg/kg midazolam before spinal anesthesia. During spinal anesthesia, a single dose of 200 microgram intrathecal morphine (0.2 ml) and 13 mg intrathecal bupivacaine will be administered. While in the second group, 0.2 ml intrathecal sodium chloride and 13 mg intrathecal bupivacaine will be applied. The drugs will be prepared in a 5 ml syringe and labeled by an anesthesiologist who will not participate in the study. The Bispectral index scores and peripheral oxygen saturation of the patients will be recorded for one hour in the operating room, then all of the patients will be sent to the post anesthesia caring unit. The patients will be assessed with Ramsey Sedation Scale at every 15 minutes for an hour by a researcher who will be blind to the study groups. Peripheral oxygen saturation levels of the patients will be recorded until the end of 120 minutes.

Sponsors

Basak Altiparmak
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

The patients who are between 18-65 years old, ASA status I-II-II and scheduled for urogenital surgeries under spinal anesthesia will be included in the study

Exclusion criteria

Known allergy to morphine or midazolam, liver or renal insufficiency, story of alcohol and substance abuse, story of opioid consumption, pregnancy, patients shorter than 160 cm, obesity, operation time longer than 60 minutes

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026