Comparison of analgesic efficacy of ketamine versus magnesium sulphate as adjuvant to intrathecal bupivacaine in parturients undergoing elective caesarean section – a randomised interventional study at SMS Medical College & attached group of hospital, Jaipur
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 1. To assess & compare between two groups the mean duration of analgesia.
Study Overview
Brief Summary
In this study, we plan to study and draw a comparison of additives like ketamine and magnesium sulphate to hyperbaric bupivacaine to determine their effectiveness in improving the overall quality of anaesthesia in parturients posted for elective caesarean sections.
For this a total of Sixty patients (n=60) undergoing elective caesarean section who satisfy the inclusion criteria will be randomly divided into two groups of 30 each(A and B). Group A patients will be receiving intrathecal ketamine (25 mg) as additive to hyperbaric bupivacaine and group B will be receiving magnesium sulphate (75 mg) as additive to hyperbaric bupivacaine.
When patients arrive in the operating room (OR), intravenous cannula (IV cannula) will be inserted and hemodynamic variables will be measured. After this spinal anaesthesia will be administered using ketamine as an additive to bupivacaine in group A and magnesium sulphate in group B. Surgery will be allowed to proceed after the block reaches T6 sensory level (complete sensory block). Quantitative values of time of onset of sensory loss, time of onset of motor loss, time taken for sensory regression, time taken for motor regression, duration of analgesia will be recorded.
Study Design
- Study Type
- Interventional
- Allocation
- Random Number Table
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 35.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •patients going for elective caesarean section under spinal anaesthesia.Patients who will give informed written consent in vernacular language.Belonging to ASA Classes II status.Height of the parturient 145–170 cm.
Exclusion Criteria
- •Patients with systemic diseases.Patients with body mass index >38kg/cm2.Patients having history of preeclampsia and eclampsia,fetal distress.
- •Patients having allergy to study drug.Patients having contraindications to spinal anaesthesia.
- •â€¢ Patients consuming tranquilizers, hypnotics, sedatives.
Outcomes
Primary Outcomes
1. To assess & compare between two groups the mean duration of analgesia.
Time Frame: Blood pressure, pluse rate, ECG, & pulse oximetry will be recorded every 5 minute intervals during the first 15 minutes of surgery & then every 15 minutes until the end of the surgery. Sensory block level will be assessed based on loss of sensation to pinprick immediately after the subject is made supine & every 1 minute thereafter until block reached T6 sensory level. The measured time will be recorded as the onset of complete sensory block, & at this time, surgery will be allowed.
2. To determine difference in mean time duration of sensory onset of spinal anaesthesia
Time Frame: Blood pressure, pluse rate, ECG, & pulse oximetry will be recorded every 5 minute intervals during the first 15 minutes of surgery & then every 15 minutes until the end of the surgery. Sensory block level will be assessed based on loss of sensation to pinprick immediately after the subject is made supine & every 1 minute thereafter until block reached T6 sensory level. The measured time will be recorded as the onset of complete sensory block, & at this time, surgery will be allowed.
between bupivacaine & ketamine versus bupivacaine and magnesium sulphate in
Time Frame: Blood pressure, pluse rate, ECG, & pulse oximetry will be recorded every 5 minute intervals during the first 15 minutes of surgery & then every 15 minutes until the end of the surgery. Sensory block level will be assessed based on loss of sensation to pinprick immediately after the subject is made supine & every 1 minute thereafter until block reached T6 sensory level. The measured time will be recorded as the onset of complete sensory block, & at this time, surgery will be allowed.
parturients undergoing elective caesarean section using pin prick method.
Time Frame: Blood pressure, pluse rate, ECG, & pulse oximetry will be recorded every 5 minute intervals during the first 15 minutes of surgery & then every 15 minutes until the end of the surgery. Sensory block level will be assessed based on loss of sensation to pinprick immediately after the subject is made supine & every 1 minute thereafter until block reached T6 sensory level. The measured time will be recorded as the onset of complete sensory block, & at this time, surgery will be allowed.
3. To assess and compare between two groups the mean time duration in motor onset
Time Frame: Blood pressure, pluse rate, ECG, & pulse oximetry will be recorded every 5 minute intervals during the first 15 minutes of surgery & then every 15 minutes until the end of the surgery. Sensory block level will be assessed based on loss of sensation to pinprick immediately after the subject is made supine & every 1 minute thereafter until block reached T6 sensory level. The measured time will be recorded as the onset of complete sensory block, & at this time, surgery will be allowed.
using bromage score.
Time Frame: Blood pressure, pluse rate, ECG, & pulse oximetry will be recorded every 5 minute intervals during the first 15 minutes of surgery & then every 15 minutes until the end of the surgery. Sensory block level will be assessed based on loss of sensation to pinprick immediately after the subject is made supine & every 1 minute thereafter until block reached T6 sensory level. The measured time will be recorded as the onset of complete sensory block, & at this time, surgery will be allowed.
4. To assess and compare between two groups the mean time duration for sensory
Time Frame: Blood pressure, pluse rate, ECG, & pulse oximetry will be recorded every 5 minute intervals during the first 15 minutes of surgery & then every 15 minutes until the end of the surgery. Sensory block level will be assessed based on loss of sensation to pinprick immediately after the subject is made supine & every 1 minute thereafter until block reached T6 sensory level. The measured time will be recorded as the onset of complete sensory block, & at this time, surgery will be allowed.
regression using pin prick sensation.
Time Frame: Blood pressure, pluse rate, ECG, & pulse oximetry will be recorded every 5 minute intervals during the first 15 minutes of surgery & then every 15 minutes until the end of the surgery. Sensory block level will be assessed based on loss of sensation to pinprick immediately after the subject is made supine & every 1 minute thereafter until block reached T6 sensory level. The measured time will be recorded as the onset of complete sensory block, & at this time, surgery will be allowed.
5. To assess and compare between two groups the mean time duration for motor regression
Time Frame: Blood pressure, pluse rate, ECG, & pulse oximetry will be recorded every 5 minute intervals during the first 15 minutes of surgery & then every 15 minutes until the end of the surgery. Sensory block level will be assessed based on loss of sensation to pinprick immediately after the subject is made supine & every 1 minute thereafter until block reached T6 sensory level. The measured time will be recorded as the onset of complete sensory block, & at this time, surgery will be allowed.
using bromage scale.
Time Frame: Blood pressure, pluse rate, ECG, & pulse oximetry will be recorded every 5 minute intervals during the first 15 minutes of surgery & then every 15 minutes until the end of the surgery. Sensory block level will be assessed based on loss of sensation to pinprick immediately after the subject is made supine & every 1 minute thereafter until block reached T6 sensory level. The measured time will be recorded as the onset of complete sensory block, & at this time, surgery will be allowed.
Secondary Outcomes
- 1. To assess & compare hemodynamic changes between the two groups.(2. Study any adverse effects associated with drugs given.)